Associate Director, Biostatistics – Oncology Biometrics
Locations: La Jolla (CA), Bothell (WA), Collegeville (PA), New York City (NY), Cambridge (MA), Groton (CT), South San Francisco (CA)
Job Type: Full-Time
Job ID: 4945385
Posted: 4 Days Ago
Position Summary
Pfizer is seeking an accomplished Associate Director, Biostatistics to support Oncology Biometrics across early- and late-phase clinical development programs. This role is responsible for independently serving as the study statistician for Phase 1–2 trials and supporting Phase 3 studies under the direction of senior biostatistical leadership. The position involves clinical study design, comprehensive statistical analysis, interpretation of clinical data, and contribution to regulatory submissions and scientific publications.
This is a hybrid role requiring onsite presence an average of 2.5 days per week.
Key Responsibilities
Clinical Study Statistical Leadership
Serve as the primary study statistician for assigned oncology clinical trials.
Provide statistically sound clinical trial designs aligned with project objectives.
Offer expert statistical input into clinical development plans.
Protocol & Analysis Development
Author statistical sections of clinical study protocols.
Develop Statistical Analysis Plans (SAPs) and collaborate with programming to create TLF shells.
Perform sample size calculations and assess operating characteristics under various assumptions.
Prepare study randomization specifications and verification documents.
Data Quality, Review & Interpretation
Review CRFs, edit checks, and support system user acceptance testing.
Review programming specifications and statistical deliverables for accuracy.
Independently derive key efficacy variables and conduct statistical analyses.
Provide expert interpretation of clinical trial results and contribute to regulatory and scientific documentation.
Cross-Functional & Departmental Collaboration
Work closely with clinical, programming, regulatory, and medical writing teams.
Contribute to timelines, ensuring high-quality statistical deliverables within agreed schedules.
Present at departmental, project team, or senior management meetings as required.
Lead or participate in cross-functional initiatives to improve processes and operational efficiency.
Minimum Qualifications
Education Requirements:
Ph.D. in Statistics, Biostatistics, or related field with 5+ years of clinical trial experience,
OR
Master’s degree in Statistics, Biostatistics, or related field with 7+ years of clinical trial experience.
Technical and Professional Requirements:
Advanced expertise in:
FDA/EMA regulations
ICH GCP guidelines
Drug development processes
CDISC standards (SDTM, ADaM)
Clinical trial statistical methodologies
Strong programming skills in R and/or SAS.
Ability to communicate complex statistical concepts across diverse audiences.
Proven ability to manage multiple concurrent projects with urgency and high accuracy.
Strong problem-solving skills with the ability to interpret high-volume, complex data.
Ability to collaborate effectively in a matrixed, cross-functional environment.
Strong organizational and prioritization skills aligned with business objectives.
Preferred Qualifications
Oncology therapeutic area experience.
Strong statistical research, simulation expertise, and methodological innovation.
Demonstrated leadership experience, including mentoring and cross-functional influence.
Work Location Assignment
Hybrid schedule: average 2.5 days per week onsite.
Compensation and Benefits
Annual base salary: $135,100 – $225,100
Eligibility for Pfizer Global Performance Plan (bonus target: 17.5%)
Eligibility for long-term share-based incentive programs
Comprehensive benefits package including:
401(k) with matching and retirement contributions
Paid vacation, holidays, and personal days
Paid caregiver/parental leave and medical leave
Medical, dental, vision, and prescription coverage
Salary ranges apply to the United States except Tampa, FL. Location-specific compensation structures apply.
Additional Information
Relocation assistance may be available based on eligibility and business needs.
Permanent U.S. work authorization is required.
Pfizer complies with federal transparency laws (Sunshine Act) related to physician payments.
Pfizer is an Equal Opportunity Employer committed to inclusive employment practices.
Pfizer participates in E-Verify for employment eligibility verification.
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