(Associate) Director, Biostatistics and Data Management
The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes ten wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.
Centessa is seeking an (Associate) Director, Biostatistics and Data Management (BSDM) to join our clinical team. The Director, Biostatistics and Data Management will provide statistical strategy and technical support as it relates to the design and statistical analysis of clinical studies. S/he will be responsible for CRO Oversight for Biostatistics and Data management CRO Deliverables as well as provide statistical input to study design for clinical protocols.
- Provide statistical leadership and support for all activities related to clinical development, including contributions to key study and program hypotheses, clinical development plans, study designs, regulatory meetings, submissions, and follow up
- Lead and manage external biostatistics, statistical programming & Data Management resources supporting studies and programs
- Applies fit for purpose and, when appropriate, innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
- Ensure accurate, statistically valid deliverables in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
- Coordinate achievement of major statistical deliverables and milestones in collaboration with the clinical development team and other functions
- Directly ensures that CRO Partner delivers high quality work products by providing senior level oversight for CRO teams. (Quality, budget, and timeline expectations) for Biostatistics & Data management
- Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, regulatory agencies, collaborating associates, vendor personnel and subcontract personnel.
- Efficiently and effectively coordinate statistical reporting activities for multiple active projects simultaneously including IND & NDA submissions.
- Ph.D. in statistics with a minimum of 10+ years of relevant work experience in a Biotech/Pharmaceutical organization
- Demonstrated ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
POSITION: Full-Time, Exempt, Flexibility for Remote Work
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.