<h3>Job Description</h3>
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
This is NOT a Remote Role and Requires a Minimum of 3-days onsite at our Gaithersburg, MD Location.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&amp;D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 
Summary of the group:
The CMC Statistics team within AstraZeneca’s Biopharmaceutical Development group supports the development of a wide range of biopharmaceuticals from pre-clinical development to commercial filing. Our statisticians and data scientists work directly with development scientists and process teams to provide expertise on experimental design and analysis and interpretation of data that is tailored to the needs and stage of the project. The number of products under development and range of modalities under investigation provides a busy collaborative environment with opportunities to provide solutions to new challenges. Biopharmaceutical Development has more than 20 years of experience on the development of biotherapeutics, has brought more than 100 molecules to the clinic and has launched 9 new therapies in the last 5 years.
Main Duties &amp; Responsibilities:
<ul>
<li>Contribute to or lead statistical thinking, analysis and reporting to relevant groups in product and study teams</li>
<li>Apply expert skills to investigate and use standard, as well as novel, statistical approaches for relevant statistical issues</li>
<li>Areas of emphasis include, design and analysis of experiments, comparability and product stability</li>
</ul>
Education &amp; Experience Requirements:
PhD in statistics or a related subject, alternatively Masters degree and 5+ years of relevant experience
Required Skills:
<ul>
<li>Deep understanding of statistical methods including mixed-models, multivariate methods, categorical data analysis, Bayesian methodologies, etc.</li>
<li>Proficiency with statistical software, R and JMP required. MatLab, Python and SAS highly desirable.</li>
<li>Must possess excellent interpersonal skills, especially when communicating statistical concepts to non-statisticians</li>
<li>Excellent written and verbal communication, business analysis, and consultancy skills</li>
<li>Customer focus - dedicated to meeting the expectations and requirements of internal and external customers</li>
</ul>
Desired Skills:
<ul>
<li>Understanding of life sciences, with a preference for pharmaceutical environment</li>
<li>Subject matter knowledge of bioproduct CMC development (cell culture, purification, analytical, formulation, devices, etc.)</li>
<li>Database programming (SQL, Oracle)</li>
<li>VBA, .NET, AWS SageMaker knowledge also desirable.</li>
</ul>
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next! 
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group <a href="https://careers.astrazeneca.com/bpd" target="_blank">https://careers.astrazeneca.com/bpd</a>
Our Social Media, Follow AstraZeneca on LinkedIn <a href="https://www.linkedin.com/company/1603/" target="_blank">https://www.linkedin.com/company/1603/</a>
Follow AstraZeneca on Facebook <a href="https://www.facebook.com/astrazenecacareers/" target="_blank">https://www.facebook.com/astrazenecacareers/</a>
Follow AstraZeneca on Instagram <a href="https://www.instagram.com/astrazeneca_careers/?hl=en" target="_blank">https://www.instagram.com/astrazeneca_careers/?hl=en</a>
Date Posted
10-Jun-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Statistician / Senior Statistician CMC Statistics (ONSITE)

<h3>Job Description</h3>
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The (Associate) Director of Biostatistics acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The (Associate) Director chips into clinical development strategies and plans. This position is hybrid and can be filled in Copenhagen, Denmark, Utrecht, The Netherlands or Princeton, NJ, US.
Compound/Indication Level
<ul>
<li>Act as lead and main point of contact related to Statistics for designated compound/indication</li>
<li>Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies</li>
<li>Engage with regulatory authorities&nbsp;on compound/indication level discussions</li>
<li>Acts as a role model</li>
<li>Ensures consistency of statistical methods and data handling across trials</li>
<li>Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor</li>
<li>Supports compound responsible programmer in developing an integrated database specification</li>
<li>CDT member:
<ul>
<li>Responsible for giving statistical input to overall strategy and the synopsis development in the CDT</li>
<li>Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques</li>
<li>Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable</li>
<li>Drive design and synopsis development together with relevant collaborators</li>
<li>Ensure clear communication to relevant partners from the CDT</li>
<li>Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs</li>
<li>Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles</li>
</ul>
</li>
</ul>
Trial Level
<ul>
<li>Represent Genmab during meetings/congresses and courses and perform professional networking</li>
<li>Engage with regulatory authorities&nbsp;on trial level discussions</li>
<li>Arranges/attends lessons learned to share takeaways</li>
<li>Represents Genmab during Key Opinion Leaders meetings&nbsp;</li>
<li>Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports</li>
<li>Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable</li>
<li>Ensures groundbreaking statistical work which includes but is not limited to:
<ul>
<li>Applying adequate methods for which a solid scientific foundation exists</li>
<li>Ensure proper documentation of work done</li>
<li>Keep oversight and QC essential documents/data provided by vendors</li>
<li>Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP</li>
</ul>
</li>
<li>CTT member:
<ul>
<li>Participate and represent Biostatistics</li>
<li>Review and provide input to protocol and amendment development</li>
<li>Perform vendor oversight according to applicable SOPs</li>
<li>Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.</li>
<li>Review assay validation reports, as applicable</li>
<li>Perform exploratory analysis, ad hoc analyses, and modelling of data</li>
<li>Review and approve randomization and stratification plans</li>
<li>Perform UAT of Randomization part of the IRT system as applicable</li>
<li>Ensure procedures for blinding are in place as applicable</li>
<li>Support timely delivery of statistical deliverables</li>
<li>Responsible for planning and conducting trial result meetings</li>
<li>Review and approve the CSR</li>
<li>Attend trial and investigator meetings if/as needed</li>
<li>Collaboration with Genmab Global Drug Safety:
<ul>
<li>Participate in definition, review, and approval of data packages for Data Monitoring Committees</li>
<li>Review and approve any amendments, corrections, and updates of data packages</li>
</ul>
</li>
</ul>
</li>
<li>CRO selection and collaboration:
<ul>
<li>Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks</li>
<li>Review scope of work (within own project) in collaboration with relevant team members and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)</li>
<li>Attend operational and steering committee meetings, as applicable</li>
</ul>
</li>
<li>Support regulatory submission/filing activities</li>
</ul>
Experience:
<ul>
<li>Master's or PhD in a statistical field&nbsp;with 8+ (AD) and 12+ years (Director) of experience in relevant technical area</li>
<li>Experience in statistical analysis, modelling and simulation and adaptive trial designs</li>
<li>Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred</li>
<li>Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics</li>
<li>Experience with the relevant regulatory requirements for biostatistics processes and SOPs</li>
<li>Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies</li>
<li>Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions</li>
<li>Experience in advising multiple complex projects/studies in a technical capacity</li>
<li>Experience leading and mentoring teams – (Director)</li>
<li>Confirmed performance in earlier role/comparable role</li>
</ul>
For US based candidates, the proposed salary band for this position is as follows:
$142,500.00---$237,500.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
<ul>
<li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li>
<li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li>
<li>You are a generous collaborator who can work in teams with diverse backgrounds</li>
<li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li>
<li>You are not afraid to grapple with the unknown and be innovative</li>
<li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li>
<li>You work hard and are not afraid to have a little fun while you do so</li>
</ul>
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.&nbsp;
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.&nbsp;
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website <a href="https://www.genmab.com/privacy" target="_blank">https://www.genmab.com/privacy</a>.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Associate Director, Biostatistics

<h3>Job Description</h3>
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role
The Senior Statistical Manager supports the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research &amp; Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents the Clinical Biostatistics function for cross-functional and intra-departmental teams or working groups.
Specifically, the Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, and/or as trial responsible statistician with responsibilities as described below and represent Biostatistics in a multidisciplinary trial team responsible for the execution of the trial (including supervision of biometrical activities performed by CROs), and be accountable for assigned biostatistics deliverables within the responsible areas. Hence, the Senior Statistical Manager should have advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support, is effective in the use of relevant computational tools for study, experiment, or trial research objectives, and applies high quality statistical methodology when working on projects with good understanding of the disease/scientific/functional area and health authority acceptability.
Responsibilities
<ul>
<li>
Compound/Indication Level
</li>
<li>
Act as lead and main point of contact related to Statistics for designated compound/indication
</li>
<li>
Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
</li>
<li>
Engage with regulatory authorities&nbsp;on compound/indication level discussions
</li>
<li>
Acts as a role model
</li>
<li>
Ensures consistency of statistical methods and data handling across trials
</li>
<li>
Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
</li>
<li>
Supports compound responsible programmer in developing an integrated database specification
</li>
<li>
Trial Level
</li>
<li>
·Represent Genmab during meetings/congresses and courses and perform professional networking
</li>
<li>
Engage with regulatory authorities&nbsp;on trial level discussions
</li>
<li>
Arranges/attends lessons learned to share learnings
</li>
<li>
Represents Genmab during Key Opinion Leaders meetings&nbsp;
</li>
<li>
Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports·&nbsp;
</li>
<li>
Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
</li>
<li>
Contribute to clinical development plans
</li>
<li>
Arrange/attend lessons learned to share learnings
</li>
<li>
Represent Genmab during external meetings/congresses
</li>
<li>
Proactively engage in department activities
</li>
<li>
Actively participate various initiatives within the department
</li>
<li>
Proactively contribute to building a global Genmab organization&nbsp;
</li>
<li>
May act as mentor for new employees or consultants
</li>
</ul>
Requirements
<ul>
<li>
MS / PhD or equivalent in a statistical discipline&nbsp;with 2+ - 5+ years of experience in relevant technical area
</li>
<li>
Experience in statistical analysis, modelling and simulation and adaptive trial designs
</li>
<li>
Experience in working with clinical trials
</li>
<li>
Preferred experience with oncology clinical trials
</li>
<li>
Proficient programming skills in statistical software’s, such as SAS
</li>
<li>
Excellent oral and written communication skills
</li>
<li>
Ability to work independently as well as in teams
</li>
<li>
Confident, self-reliant, and a quick learner
</li>
<li>
Proactive and open minded
</li>
<li>
Ability to prioritize and work in a fast-paced and changing environment
</li>
<li>
Result and goal-oriented and committed to contributing to the overall success of Genmab
</li>
</ul>
For US based candidates, the proposed salary band for this position is as follows:
$114,375.00---$190,625.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
<ul>
<li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li>
<li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li>
<li>You are a generous collaborator who can work in teams with diverse backgrounds</li>
<li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li>
<li>You are not afraid to grapple with the unknown and be innovative</li>
<li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li>
<li>You work hard and are not afraid to have a little fun while you do so</li>
</ul>
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.&nbsp;
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.&nbsp;
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website <a href="https://www.genmab.com/privacy" target="_blank">https://www.genmab.com/privacy</a>.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Manager/Senior Manager, Biostatistics

<h3>Job Description</h3>
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role The Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Director contributes to clinical development strategies and plans. Responsibilities:
Compound/Indication Level
<ul>
<li>Act as lead and main point of contact related to Statistics for designated compound/indication</li>
<li>Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies</li>
<li>Engage with regulatory authorities&nbsp;on compound/indication level discussions</li>
<li>Acts as a role model</li>
<li>Ensures consistency of statistical methods and data handling across trials</li>
<li>Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor</li>
<li>Supports compound responsible programmer in developing an integrated database specification</li>
</ul>
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; CDT member:
<ul>
<li>Responsible for giving statistical input to overall strategy and the synopsis development in the CDT </li>
<li>Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques </li>
<li>Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable </li>
<li>Drive design and synopsis development together with relevant stakeholders </li>
<li>Ensure transparent communication to relevant stakeholders from the CDT </li>
<li>Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs </li>
<li>Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles</li>
</ul>
Trial Level
<ul>
<li>Represent Genmab during meetings/congresses and courses and perform professional networking</li>
<li>Engage with regulatory authorities&nbsp;on trial level discussions</li>
<li>Arranges/attends lessons learned to share learnings</li>
<li>Represents Genmab during Key Opinion Leaders meetings&nbsp;</li>
<li>Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports</li>
<li>Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable</li>
<li>Ensures state of the art statistical work which includes but is not limited to:</li>
<li>Applying adequate methods for which a solid scientific foundation exists</li>
<li>Ensure proper documentation of work done</li>
<li>Keep oversight and QC essential documents/data provided by vendors</li>
<li>Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP</li>
</ul>
CTT member:
<ul>
<li>Participate and represent Biostatistics</li>
<li>Review and provide input to protocol and amendment development </li>
<li>Perform vendor oversight according to applicable SOPs</li>
<li>Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc. </li>
<li>Review assay validation reports, as applicable </li>
<li>Perform exploratory analysis, ad hoc analyses, and modelling of data </li>
<li>Review and approve randomization and stratification plans </li>
<li>Perform UAT of Randomization part of the IRT system as applicable </li>
<li>Ensure procedures for blinding are in place as applicable </li>
<li>Support timely delivery of statistical deliverables </li>
<li>Responsible for planning and conducting trial result meetings </li>
<li>Review and approve the CSR </li>
<li>Attend trial and investigator meetings if/as needed </li>
<li>Collaboration with Genmab Global Drug Safety:</li>
<li>Participate in definition, review, and approval of data packages for Data Monitoring Committees </li>
<li>Review and approve any amendments, corrections, and updates of data packages</li>
<li>Support regulatory submission/filing activities</li>
</ul>
 Requirements:
<ul>
<li>Master's or PhD in a statistical discipline&nbsp;with 12+ years of experience in relevant technical area</li>
<li>Experience in statistical analysis, modelling and simulation and adaptive trial designs</li>
<li>Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred</li>
<li>Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics</li>
<li>Experience with the relevant regulatory requirements for biostatistics processes and SOPs</li>
<li>Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies</li>
<li>Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions</li>
<li>Experience directing multiple complex projects/studies in a technical capacity</li>
<li>Experience leading and mentoring teams</li>
<li>Proven performance in earlier role/comparable role</li>
</ul>
This role can be based in Copenhagen, Denmark; or Princeton, NJ USA and is hybrid.
For US based candidates, the proposed salary band for this position is as follows:
$170,625.00---$284,375.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
<ul>
<li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li>
<li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li>
<li>You are a generous collaborator who can work in teams with diverse backgrounds</li>
<li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li>
<li>You are not afraid to grapple with the unknown and be innovative</li>
<li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li>
<li>You work hard and are not afraid to have a little fun while you do so</li>
</ul>
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.&nbsp;
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.&nbsp;
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Director, Biostatistics

<h3>Job Description</h3>
Job Description
Job Description
Company Descriptions:
Wizsolution is located in Princeton NJ, which is a leader in pharmaceutical recruitment and staffing. Our goal is to provide effective solutions for fulfilling your career potential. The mission of our company is to connect high talent and motivated candidates to technical positions from our partner companies.
Job descriptions:
Senior SAS Programmer Senior Statistical Programmer
*
-Perform SAS data manipulation and analysis programming -May work with medical writing, clinical operations, and other clinical staff to support deliverables. -Must work well both independently and with team members. -Needs to be able to be on-time with deliverables, and for those deliverables to be of quality. -Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed. -Plans and carefully documents differences between programming results between program developer and Statistical QC programmer. -Confirms that tracking sheets are current for projects, and may also confirm that results are consistent with earlier generated results.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; MS with 3-5 +years of pharmaceutical industry experience.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong collaboration abilities and ability to work as part of a highly skilled team.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience in CDISC (SDTM, ADaM data sets)
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Skilled in analysis of safety, efficacy &amp; biomarker data, with an understanding of multiplicity issues; immunology/CV background a plus.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experienced with standard and advanced statistical methods.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Expertise in SAS required, S-Plus or R preferred, including advanced statistical analysis, data integration, graphing &amp; simulation.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong programming skills.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Good understanding of regulatory requirements &amp; clinical trial design.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Knowledge of and ability to learn relevant clinical background and biomarker biology and incorporate these into statistical design, analysis &amp; interpretation.
Preferred Qualifications:
Must have 3-5+&nbsp;years SAS Programmer experience SAS systems experience may include Base SAS, SAS/FSP,SAS SCL, Macro Facility, SAS/Graph, SAS / ODS, and SAS / Stat within a Windows operating system.
Job Type: Full-time

Senior SAS/Statistical Programmer

<h3>Job Description</h3>
Job Description
Bio-statistician is required to conduct statistical analysis, modelling, and reporting activities in pharmaceutical industry.

Biostatistician

<h3>Job Description</h3>
Inova Health System is seeking a Radiology Technologist Director for a job in Falls Church, Virginia.
Job Description &amp; Requirements
<ul>
<li>Specialty: Radiology Technologist</li>
<li>Discipline: Allied Health Professional</li>
<li>Start Date: ASAP</li>
<li>Duration: Ongoing</li>
<li>Employment Type: Staff</li>
</ul>
 The Division of Pediatric Cardiology at Inova LJ Murphy Children’s Hospital is seeking a full-time pediatric cardiologist to serve as Medical Director of Non-Invasive Cardiovascular Imaging to support our rapidly growing team within Inova Children’s Heart Center. The Heart Center at INOVA L.J Murphy Children’s Hospital has been caring for the children of Northern Virginia and the Greater Washington Region for more than 30 years. Each year, the program is responsible for approximately 550 procedures. The program provides surgical repair of the most complex congenital heart defects, including hypoplastic left heart syndrome. In addition to providing care for children with complex congenital anomalies, the program provides a lifetime of care as part of the Inova Schar Heart and Vascular, which includes the Adult Congenital Program. Inova Children’s Heart Center is a comprehensive team, including congenital cardiac surgery, outpatient cardiology, fetal cardiology, non-invasive cardiology, adult congenital cardiology, diagnostic and interventional catheterization, and electrophysiology and advanced heart failure therapies. The team includes 23 board-certified pediatric cardiologists, 8 pediatric cardiac intensivists, 3 pediatric cardiac surgeons and 17 advanced practice providers. With respect to non-invasive imaging, the division currently performs fetal, transthoracic, and transesophageal echocardiography, and partners with radiology on cMRI and CT scans. A team of inpatient and outpatient dedicated congenital sonographers support the division. The Pediatric Noninvasive Imaging Lab (ICAEL accredited) at Inova Children’s Hospital is the largest program in Virginia performing 11,000 outpatient and 2,600 inpatient echocardiograms per year. Inova LJ Murphy Children’s Hospital is a 226-bed children’s hospital at Inova Fairfax Hospital medical campus, located in Northern Virginia. As the only dedicated children’s hospital and pediatric heart center in Northern Virginia, we provide care in a welcoming environment that offers the latest in technical innovation in kid-friendly spaces. The children’s hospital has a 108-bed, level IV Neonatal Intensive Care Unit with approximately 17,000 annual deliveries. The Pediatric Cardiac Intensive Care Unit and Acute Care Step-Down Unit are part of the Inova Children’s Heart Center. We are seeking a Board Certified/Eligible Pediatric Cardiologist committed to a career in Pediatric Cardiology with advanced training in pediatric echocardiography to join our growing and dynamic practice as Echo (Noninvasive Imaging) Lab Director. Our ideal candidate will be energetic, enthusiastic, and work effectively as part of a team. The candidate must be an outstanding clinician dedicated to the care of hospitalized children and their families, and an excellent mentor for junior echo attendings. Key Responsibilities: - Professional responsibilities will include directing noninvasive imaging for the Pediatric Heart Center. - Support and mentor junior and mid-career pediatric cardiology echo attendings within the Pediatric Heart Center. - Support and mentor ultrasound technicians within the Pediatric Heart Center. - The candidate should have advanced training in non-invasive imaging while possessing professional, clinical, and leadership skills. - This position will work with the Chief of Pediatric Cardiology and the leadership of the Inova Children’s Heart Center to execute on yearly personal and programmatic goals focused on the fundamentals of extraordinary care: Safety, quality, patient experiences, access, and stewardship. - This is a perfect position for the candidate that thrives in an environment that focuses on teamwork, collaboration and dedication to patients, families, and each other. - Although patient care is our primary focus, education and research are also encouraged and supported with access to dedicated research professionals including a statistician, research manager, and research coordinators. Position Highlights: - Highly competitive salary with incentives - Full Medical, dental and vision - Generous PTO and paid time to attend CME. - Paid Parental Leave Program - Located Northern Virginia Requirements: - Board-certified/eligible in Pediatric Cardiology - Interested individuals should be board-certified in Pediatric Cardiology and able to obtain an unrestricted Virginia Medical License. - The ideal candidate will have extensive experience (5+ years) in the field, specifically in echocardiography (TTE, TEE, strain analysis and 3D imaging) - Preference will be given to those with experience at higher volume centers and demonstrated leadership roles in imaging. - Additional preference will be given to those with previous experience or education in medical administration and those who have clinical research experience. - Eligible for faculty appointment at The University of Virginia School of Medicine
Inova Job ID #641086. Posted job title: medical director, pediatric non-invasive cardiovascular imaging

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