Principal Biostatistician

4 months ago


Montgomery, United States Kenvue Full time

Kenvue is currently recruiting for:


Principal Biostatistician

This position reports to the Director Global Biostatistics and is based in Skillman, NJ.


Who we are

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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: Director Global Biostatistics

Location: Skillman, NJ Kenvue’s corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.

Travel %: 10%


What you will do

The biostatistician in this role provides study-level statistical expertise in support of the design, analysis, and interpretation of clinical trials through collaboration with other team personnel including clinical research, clinical operations, data management, and programming. This support includes statistical aspects of study design, protocol review, and preparation of statistical sections; preparation of the statistical analysis plan; oversight of tables/listings/figures development; interpretation of results to internal clinical and management personnel; and support of the preparation of publications and submissions of regulatory deliverables. In providing clinical trial support, this person will participate in management of external resources to ensure quality, timely, and cost-effective statistical deliverables.


Responsibilities:

  • Represent the biostatistics function in supporting the design, analysis, and interpretation of clinical trials through collaboration with other functions including Clinical Research, Clinical Operations, Data Management, and Programming
  • Provide statistical input to clinical plans in support of product development, claims, and submissions
  • Provide statistical support to the development and review of study protocols, statistical analysis plans, clinical study reports, and regulatory submissions
  • Participate in oversight of biostatistics activities of external vendors to ensure quality and timeliness of statistical deliverables
  • Assist clinical and other personnel in the creation of publications and manuscripts
  • Support the development and implementation of process efficiencies and continuous improvements to decrease cycle time and reduce cost while maintaining/improving quality.
  • Support interactions with and responses to regulatory agencies.
  • Ensure compliance with all statistical analysis and reporting procedures


What we are looking for

Required Qualifications

  • Graduate degree in Statistics or a related quantitative field
  • PhD degree or equivalent with 2+ years relevant experience; or MS degree or equivalent with 4+ years relevant experience
  • Experience in a pharmaceutical setting
  • Experience with statistical computing software preferably including SAS
  • Excellent oral and written communication skills, and strong interpersonal skills
  • Excellent problem-solving skills
  • Effective collaboration in cross-functional teams


Desired Qualifications

  • Solid statistical background, with application to clinical trials
  • Scientific curiosity, eagerness to grow in statistical knowledge and applications
  • Excellent team player
  • Excellent communication skills


What’s in it for you

  • Competitive Total Rewards Package*
  • Paid Company Holidays, Paid Vacation, Volunteer Time & More
  • Learning & Development Opportunities
  • Employee Resource Groups


*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 business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.