Principal Biostatistician

Kenvue•Summit, NJ

8d•Hybrid

About The Position

Kenvue is currently recruiting for a: Principal Biostatistician 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 Biostatistics Location: North America, United States, New Jersey, Summit Work Location: Hybrid What 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.

Requirements

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.

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.