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

• Demonstrated high aptitude (subject matter expert) typically with a Ph.D. in Statistics, Biostatistics or related field with 5+ years of experience, or a master‚Äôs degree with 7+ years of experience in clinical trials.
• 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.
• Demonstrated ability to develop and deliver multi-mode communications, manage multiple projects, take on new opportunities with energy and urgency, and consistently achieve results; adapt approach to shifting demands; build partnerships; solve complex problems; plan and prioritize work.

Skills

• Statistical design and analysis for clinical trials
• Clinical development planning
• Protocol and statistical section authoring
• Statistical analysis plans, data interpretation, and reporting
• Randomization design and verification
• Sample size calculations and operating characteristics
• CRF review and UAT participation
• Dataset programming review and deliverable preparation
• Leadership in cross-functional teams

Education

• Ph.D. in Statistics, Biostatistics or related field with 5+ years of clinical trials experience, or
• Master‚Äôs in Statistics, Biostatistics or related field with 7+ years of clinical trials experience

Additional Requirements

• Onsite/hybrid work arrangement: Hybrid, must be onsite an average of 2.5 days per week