Associate Director, Biostatistics (late-stage)

Role Summary

The Associate Director, Biostatistics will provide statistical leadership in one or more therapeutic areas, oversight of clinical development planning and execution for multiple indications at Centessa.

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 (e.g., 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
• 5+ years of 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

Additional Requirements

• Remote role based in the US, with infrequent travel to Boston, MA (less than 10%).