(Associate) Director, Biostatistics
About The Position
As the (Associate) Director of Biostatistics, you will provide oversight of clinical development planning and execution across one or more therapeutic areas, primarily for late-phase clinical studies. Reporting to the Executive Director, Biostatistics, you will ensure that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards. This role requires strong statistical and cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company’s goals.
Requirements
- PhD in Statistics or Biostatistics
- 10+ years of post-PhD experience applying statistical methods in the pharmaceutical industry.
- Demonstrated experience supporting late-stage (registrational) trials, including experience with regulatory submissions.
- Ability to use SAS and/or R programming languages to perform analyses, conduct statistical modeling, and validate important data derivations
- Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
- Ability to work in a cross-functional matrix environment, and proactively influence teams with innovative clinical development strategy
- Demonstrates breadth of diverse leadership experiences and capabilities including: the ability to develop and coach other colleagues to achieve meaningful outcomes and create business impact
- Consistently demonstrates strong oral and written communication skills
Nice To Haves
- Knowledge and experience in neurology and/or oncology therapeutic areas preferred
- Experience of interacting with regulatory agencies, including FDA and EMA, highly desirable
Responsibilities
- Lead biostatistics efforts in a team setting and focus on business priorities
- Collaborate on clinical development plan for one or more molecules to provide biostatistical perspective and insight
- Determine innovative study designs, appropriate statistical tests and methods for evaluating and generating statistical hypotheses to meet study and regulatory requirements
- At study level, author and review statistical sections for protocols, statistical power and sample size estimate, randomization schemes, clinical study reports, and regulatory submission documents
- Lead the planning, organization and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for assigned products
- Work with cross-functional team to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
- Lead and guide third-party statistical vendors and contractors in the execution of relevant deliverables (eg, TLFs, SAPs, blinding plans)
- Oversee preparation, conduct, and execution for Data Monitoring Committee meetings
- Maintain expertise in state-of-the-art statistical methodologies and statistical analyses
- Collaborate with Data Management to ensure data integrity and quality
Benefits
- In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.
- Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
