Principal Biostatistician
Role reports to:Associate Director Biostatistics
Location:North America, United States, New Jersey, Summit
Work Location:Hybrid
What you will doPrincipal Biostatistician manages the operations of the biostatistics functions of the department, including activities related to the design and analysis of clinical trials, data submission and ensure the project success, support the data interpretation and date reporting activities and publication strategy.
Key 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.
- Support clinical investigators with statistical input and contribute to data interpretation, reporting activities, and scientific publications.
What We're Looking For- 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.
- Strong ethical judgment and commitment to quality, compliance, and Credo-based decision-making.
- Ability to contribute insights, challenge the status quo, and support innovative, data-driven solutions.
- Demonstrated capability to identify risks, make effective decisions, manage priorities, and deliver results with speed and accountability.
- Commitment to personal development and supporting team and talent growth; values diverse perspectives and fosters a trusting, collaborative environment.
- Scientific curiosity and eagerness to grow expertise in statistical applications for clinical trials.
What's in it for youAnnual base salary for new hires in this position ranges:
$127.075,00 - $179.400,00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
- Competitive Benefit Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Kenvuer Impact Networks
- This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
