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
The Associate Director/Director, Biostatistics will provide statistical leadership in one or more therapeutic areas, oversight of clinical development planning and execution for multiple indications at Centessa.
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, Biostatistics, or related field
- 8+ years of experience applying statistical methods in the pharmaceutical industry, with early (Phase 1 and Phase 2) and late (registrational) trial experience.
- 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
Work Location
The Associate 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
Centessa Pharmaceuticals Boston, Massachusetts, USA Office
1 Federal Street. 38th Floor, Boston, MA, United States, 02110
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