Associate Director, Biostatistics

Key Skills

Analytical and Problem solving, Biostatistics, Data management, Design, Effective communication skills, Leadership Skill, Operations, SAS

Job Description

What will you 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.

Key Responsibilities

• 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 approve protocols for statistical and related content.
• 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 a related quantitative field; PhD degree or equivalent with 8+ years relevant experience; or MS degree or equivalent with 10+ years relevant experience
• Strong statistical background, with expertise in clinical trials
• Pharmaceutical setting experience in clinical development biostatistics methods and processes
• Experience in regulatory interactions and submissions preferred
• Experience with statistical computing software, preferably including SAS
• Scientific curiosity, eagerness to grow in statistical knowledge and applications, enthusiasm for innovation
• 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
• Excellent team player

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 candidate will be based in Skillman, NJ and may require up to 10% domestic and/or international travel as needed by the business.

The anticipated base pay range for this position is $131,000 to $225,400

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.