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Associate Director, Biostatistics

5+ years
$135,100 – $225,100
10 Nov. 20, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.