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, and provides statistical input to study designs while contributing to departmental or cross-functional initiatives to enhance processes and 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 a clinical study team setting.
• May independently present at department, project team, or Sr. Management meetings.
• May lead inter-department projects involving other contributors.

Qualifications

• Minimum Qualifications:
  • Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or
  • Master’s degree in Statistics, Biostatistics or related field 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 and tough challenges with urgency, and consistently achieve results
  • Ability to adapt to shifting demands, build partnerships, and solve complex data problems
  • Plan and prioritize work to meet organizational goals
• Preferred Qualifications:
  • Oncology experience
  • Strong statistical research and simulation skills and experience
  • Leadership capabilities including influencing, coaching others, and guiding colleagues to achieve meaningful outcomes

Skills

• Statistical design and analysis
• Clinical trial methodology
• Regulatory submission support and publication contributions
• Data interpretation and communication of complex results
• Collaboration across cross-functional teams

Additional Requirements

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