Sr BioStatistician (Clinical Trials)

Job Description

Job Description

Overview –

• In this exciting role as a Senior Statistician, you will have primary focus responsibility to support innovative cardiovascular device and ablation device clinical trials and contribute to efforts in the field of advanced analytics and data solutions. The Senior Statistician will support Cardiac Rhythm Management (CRM), and Cardiac Ablation Solutions (CAS) .
• Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. This role will support the design, analysis and publication of clinical trial data.

Responsibilities –

· Qualifications:

o Advanced degree (Master’s required)

o Experience working directly with clinical trials (design, analysis, or execution)

o Biostatistics background preferred

· Technical Skills:

o Proficiency in SAS statistical software

o Experience in the medical device industry

o Knowledge of R statistical software (beneficial but not required)

· Key Focus:

o Emphasis on the design side of clinical trials

• Responsibilities may include the following and other duties may be assigned. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
• Provides specifications and directions to the clinicians/statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Qualification & Requirements –

• Education Required: Advanced degree with a minimum of 2 years of statistical experience (e.g., statistical modeling, biostatistics)

Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.

Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Company Description

Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities