Executive Director, Biostatistics and Data Management

Summary

Join Arvinas, a clinical-stage biotechnology company, as the Executive Director of Biostatistics and Data Management. This critical leadership role involves developing and implementing strategic plans for Arvinas' clinical developments. You will provide technical support for ongoing clinical trials, FDA submissions, and publications. The position reports to the Chief Medical Officer and offers remote, hybrid, or on-site options in New Haven, CT. Responsibilities include leading biostatistics strategy, providing statistical leadership in clinical development, overseeing CROs and vendors, collaborating cross-functionally, developing department standards, building and mentoring teams, and identifying opportunities for innovative statistical methodology. Arvinas offers a competitive compensation and benefits package.

Requirements

• 15+ years of experience in pharmaceutical/biotech clinical drug development
• 10+ years of oncology experience is required
• Proficiency in statistical programming languages/software such as SAS, R, etc
• Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process
• Demonstrated written and oral communication skills and ability to work within a team and work independently are required
• Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability
• Desire to work in a fast-paced, innovative environment
• Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future
• The duties of this role are generally conducted in a combination of lab and home office environments. Employees must be able, with or without an accommodation to lift/carry 15/30 pounds unassisted/assisted; work comfortable in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours
• Ph.D. in Statistic, Biostatistics, Mathematics or related field

Responsibilities

• Be accountable for leading the biostatistics strategy in all Arvinas clinical development projects
• Provide statistical leadership into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives
• Provide oversight of CRO and statistical vendors externally to ensure quality of all statistical deliverables and adherence to requirements/timeline
• Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, clinical operations, medical affairs, medical writing etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program
• Develop and implement department standards, processes and practices to ensure statistical integrity of project deliverables
• Build biostatistics talent team at Arvinas. Develop and mentor junior statisticians to help grow the department
• Oversee data management team at Arvinas. Develop and mentor data management team to help grow the department
• Develop functional biostatistics infrastructure and capabilities
• Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
• Incorporate generative AI into the workflow of the group and document increased efficiency

Preferred Qualifications

Past NDA/BLA submission experience is preferred

Benefits

• Group medical, vision and dental coverage
• Group and supplemental life insurance