Associate Director, Biostatistics

Role Summary

The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role is an individual contributor who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency.

Responsibilities

• Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
• Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner.
• Provide statistical inputs on clinical development plans.
• Contribute to the development of clinical study protocols and author the statistical sections.
• Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses.
• Develop study randomization specification and verification documents as necessary.
• Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives.
• Review CRFs and edit checks and participate in UAT of different systems.
• Review dataset programming specifications, key derived variables, and statistical deliverables.
• Independently derive from source data key efficacy variables and analyses.
• Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations.
• Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner.
• Provide statistical leadership in clinical study team setting.
• May independently present at department, project team, or Sr. Management meetings.
• May lead inter-department projects involving other contributors.

Qualifications

• Required: Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a Master’s degree with 7+ years of experience in clinical trials.
• Required: High aptitude in FDA/EMA and other regulations; ICH GCP guidelines; drug development process; CDISC standards and implementation guides; statistical methods and applications to clinical trial design and data analysis; programming skills in R and/or SAS; company SOPs and business practices.
• Required: Demonstrated ability to develop and deliver multi-mode communications, manage multiple projects, take on new opportunities with urgency and energy, consistently achieve results, adapt to shifting demands, build partnerships, solve complex problems, and plan/prioritize work.
• Preferred: Oncology experience; strong statistical research and simulation skills; leadership capabilities including the ability to influence, coach, and guide others to achieve outcomes.

Skills

• FDA/EMA and other regulatory knowledge
• ICH GCP guidelines
• Drug development process understanding
• CDISC standards and implementation guides
• Statistical methods and clinical trial design and data analysis
• Programming in R and/or SAS
• Company SOPs and business practices
• Effective written and verbal communications; presentations
• Project management and multitasking
• Adaptability and proactive problem solving
• Collaborative teamwork and cross-functional partnership

Additional Requirements

• Work Location: Hybrid, onsite an average of 2.5 days per week