Principal Biostatistician

Job Description

Job DescriptionOverview:

Recognized in 2024 by Seramount as one of the 100 Best Companies for Working Parents and Caregivers, the company also earned a place on the 2024 US Inclusion Index and Global Inclusion Index across 7 countries - Brazil, Canada, China, Germany, India, Japan, and the UK.

This is a global organization in the consumer health and personal care industry, with 135+ years of heritage, 22,000+ employees, and a presence across 100+ countries. Its portfolio includes iconic consumer health and personal care brands used by millions of people worldwide.

Benefits:

• Competitive benefits package.
• Paid time off.
• Health insurance benefits, including coverage for doctor visits and mental health care.
• Retirement program.
• Employee Assistance Program (EAP) and mental well-being resources.
• Global exercise/well-being reimbursement.
• Adoption, fertility, and surrogacy benefits.
• Global parental leave.
• Paid company holidays and volunteer time.
• Learning and development opportunities.

Qualifications

• Graduate degree in Statistics or related quantitative field; typically 4+ years industry experience with a PhD or 6+ years with an MS.
• Strong background in clinical development biostatistics, statistical methods, and industry processes.
• Proficiency in SAS or R programming.
• Excellent communication, collaboration, problem-solving, and interpersonal skills; effective working in cross-functional teams.
• Advanced knowledge of working with CDISC and related FDA standards for the specification and creation of SDTM and ADaM datasets.

Responsibilities

• Lead and manage biostatistics operations for clinical development programs, ensuring high-quality design, analysis, reporting, and interpretation of clinical trial data.
• Serve as the Lead Statistical SME, applying appropriate statistical methodologies in alignment with established procedures and regulatory expectations.
• Oversee statistical activities at the project level, including vendor oversight and ensuring compliance with statistical analysis and reporting standards.
• Collaborate cross-functionally and with external partners to support project success, publication strategies, and manuscript development.
• Provide statistical support for regulatory submissions and interactions with health authorities.