COMPANY

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 Director/Sr. Director in Biostatistics will provide statistical leadership in one or more therapeutic areas (hematology, oncology, neurology), including oversight of pre-clinical and clinical development planning and execution for multiple indications at Centessa. The position will oversee coordination of statistical support efforts across these indications.

Key Responsibilities

• Lead biostatistics efforts in a team setting 
• Collaborate with Clinical Development personnel on clinical study design
• Determine innovative study designs, appropriate statistical tests and methods for both evaluating and generating statistical hypotheses to support studies, which meet regulatory requirements
• At study level, design and write statistical sections for protocols, case report forms, data management plans, statistical power and sample size estimates, randomization schemes, clinical study reports, and regulatory submission documents
• Participate in cross-functional clinical development planning for one or more molecules to provide the biostatistical perspective and biostatistical input.
• Lead the gathering, 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 readout for Data Monitoring Committee meetings
• Maintain expertise in state-of-the-art data statistical methodologies and statistical analyses
• Collaborate with Data Management to ensure data integrity and quality

Qualifications

• MSc (PhD preferred) in Statistics, Biostatistics, or related field
• Minimum of 8 years' experience applying statistical methods in the pharmaceutical industry, with both early (Phase 1 and Phase 2) and late (registrational) trial experience highly desired
• Experience in hematology, oncology, and/or neurology therapeutic areas preferred, albeit not required
• Ability to use SAS and/or other programming languages (R, JMP, nQuery, EAST, etc.) to perform efficacy analyses, conduct statistical modeling, and validate important data derivations when necessary
• Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
• Experience interacting with regulatory agencies, including FDA and EMA, up to and including marketing applications, highly desirable
• Demonstrates strong communication skills, both oral and written
• Ability to work in a cross-functional matrixed environment, and proactively influence teams with innovative clinical development strategy
• Demonstrates breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes, and create business impact

Work Location

The Director/Sr. Director in 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.