Associate Director, Biostatistics

Centessa Pharmaceuticals, LLC; Boston (MA); Remote; USD 120,000 - 170,000; Full time

Job summary

Centessa Pharmaceuticals is seeking a remote Director/Associate Director in Biostatistics. The successful candidate will lead statistical efforts in clinical development across therapeutic areas, focusing on innovative study designs, collaborating with cross-functional teams, and maintaining data integrity. This full-time position requires a strong background in statistics and experience in the pharmaceutical industry, particularly in early and late-stage trials.

Qualifications

• Minimum of 6 years in the pharmaceutical industry with trial experience.
• Knowledge in neurology and/or oncology therapeutic areas preferred.
• Experience with FDA and EMA interactions highly desirable.

Responsibilities

• Lead biostatistics efforts in clinical development.
• Author and review statistical sections for protocols and reports.
• Collaborate on clinical development plans and ad hoc analysis.

Skills

Statistical methods

Communication skills

SAS programming

R programming

Leadership

Education

MSc in Statistics or Biostatistics

PhD preferred

Tools

CDISC standards

Job description

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/Associate Director in 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

• MSc (PhD preferred) in Statistics, Biostatistics, or related field
• Minimum of 6 years' experience applying statistical methods in the pharmaceutical industry, with early (Phase 1 and Phase 2) and late (registrational) trial experience highly desired
• Knowledge and experience in neurology and/or oncology therapeutic areas preferred
• Ability to work in a cross-functional matrix environment, and proactively influence teams with innovative clinical development strategy
• Experience of interacting with regulatory agencies, including FDA and EMA, highly desirable
• Demonstrates strong communication skills, both oral and written
• 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
• 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.

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