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Form of work Kenvue is currently recruiting for an Associate Director Biostatistics, as part of our Quantitative Sciences group. This position will be located in Skillman, NJ, and will collaborate with our Global Consumer and OTC clinical project teams.
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® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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.
What You Will Do
The Associate Director Biostatistics provides departmental leadership and statistical leadership in the design, analysis, and interpretation of clinical trials. This leadership includes expert statistical input into statistical aspects toward study design, analysis plans, and strategic planning in line with business objectives; collaboration with other functions including clinical research, clinical operations, data management, and regulatory affairs; management of internal and external resources; and collaborating in interactions with and submissions to regulatory agencies. This role also participates in preparation and improvement of relevant standard operating procedures.
Objectives of the Position
- Represent the biostatistics function in 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 expert statistical input to study design and analysis plans for clinical trial protocols, and statistical input to strategic planning in line with business objectives. Review and develop statistical and related content for protocols.
- Manage internal resources and external vendors to ensure project success
- Assist clinical and other personnel in the creation of publications and manuscripts
- Collaborate in interactions with and submissions to regulatory agencies
- Develop and ensure that statistical analysis and reporting procedures comply with relevant regulations, guidance, directives, and standards, including preparation and maintenance of relevant standard operating procedures
- Assist in the development and implementation of process efficiencies and continuous improvements to decrease cycle time and reduce cost while maintaining/improving quality
- Participate in the recruitment of high caliber professionals to strengthen the business
Qualifications
What We Are Looking For
Required Qualifications:
- Graduate degree in Statistics or Biostatistics or a related quantitative field
- PhD degree or equivalent with 8 years relevant experience; or MS degree or equivalent with 10 years relevant experience
- Pharmaceutical setting experience in clinical development biostatistics methods and processes
- 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 both internal and external to the organization
- Experience in regulatory interactions and submissions
- Scientific curiosity, eagerness to grow in statistical knowledge and applications, enthusiasm for innovation
- Excellent team player
The anticipated base pay range for this position is $135,000 to $232,300.
What's In It For You
• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.
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