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 (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.
Key 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
Qualifications
- 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.
- Knowledge and experience in neurology and/or oncology therapeutic areas preferred
- Experience of interacting with regulatory agencies, including FDA and EMA, highly desirable
- 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
Compensation
The annual base salary range for the Director job level is $190,000.00 to $250,000.00.
The annual base salary range for the Associate Director job level is $170,000.00 to $225,000.00.
Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.
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.
Work Location
The Director, Biostatistics is a remote role based in the US, with infrequent (<10%) travel to our headquarters in Boston, MA.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Top Skills
What We Do
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a Research & Development innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology. We are led by a management team with extensive R&D experience, providing direct guidance to our program teams to rapidly advance our candidates from research through all stages of development. We are headquartered in Boston, Massachusetts
