Director, Biostatistics

Centessa Pharmaceuticals, LLC•Boston, MA

3h•$190,000 - $250,000•Remote

About The Position

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role As the 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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