Principal Biostatistician
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What you'll do
- 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 they'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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Kenvue is currently recruiting for a:
What we do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.
Role reports to:
Associate Director BiostatisticsLocation:
North America, United States, New Jersey, SummitWork Location:
HybridWhat you will do
Principal 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 you
Annual base salary for new hires in this position ranges:
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.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Company
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