Manager, Biostatistics

Job Summary

The Manager, Biostatistics is a biostatistician who can work with minimal supervision on statistical aspects associated with clinical trials. The person in this role:

• Is an individual contributor who can create clinical study designs, perform data analysis, provide data interpretation, and contribute to clinical publications.
• Provides statistical input to clinical development planning.
• Contributes to departmental or cross‑functional initiatives to enhance business processes and improve efficiency.

• Under supervision by senior statistician, serve as a study statistician for clinical studies related to one or more clinical programs.
• Work with senior level statistician to provide statistically sound experimental design and data analysis strategies to meet project objectives and regulatory requirements with high quality in a timely manner.
• 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.
• 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 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.
• Participate in the development and maintenance of department tools, templates, and guidelines.
• Contribute to department initiatives and promote best practices.
• May independently present at department or project team meetings.

• Demonstrated proficiency (teaches others, makes improvements) in key areas of responsibility, which is typically associated with a master’s degree in Statistics or Biostatistics with minimum 2 years of experience in an applied statistics setting, or a Ph.D. in Statistics, Biostatistics, or a comparable quantitative field.
• Ability to learn/gain working knowledge of:
  • FDA/EMA or other regulations
  • ICH GCP guidelines
  • Drug development process
  • CDISC standards and implementation guides
  • Company SOPs and business practices
• Proficient in:
  • Statistical methods and applications to clinical trial design and data analysis
  • Programming skills in R and/or SAS
• Demonstrated ability to:
  • Develop and deliver multi‑mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences.
  • Take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
  • Consistently achieve results, even under tough circumstances.
  • Adapt approach and demeanor in real time to match the shifting demands of different situations.
  • Build partnerships and work collaboratively with others to meet shared objectives.
  • Make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

• Clinical trial experience.
• Statistical research and simulation skills.
• Strong written and verbal communication skills.
• Demonstrated ability to work effectively as a part of an interdisciplinary team.

Hybrid, must be onsite an average of 2.5 days per week.

The annual base salary for this position ranges from $ to $. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy…