Associate Director, Biostatistics
Pfizer, San Diego, CA, United States
Responsibilities
Serve as 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 coordinate with programming to create table, listing and figure shells for clinical trials or ad‑hoc analyses.
Develop study randomization specifications and verification documents.
Perform sample size calculations and assess trial design operating characteristics under various assumptions.
Advise the team on efficient design to meet study objectives.
Review CRFs, edit checks, and participate in UAT of different systems.
Review dataset programming specifications, key derived variables, and statistical deliverables.
Independently derive key efficacy variables and analyses from source data.
Analyze clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of trial results to regulatory authorities and the scientific community.
Review and contribute to study and project timelines, providing high‑quality statistical deliverables in a timely manner.
Provide statistical leadership within clinical study teams.
Present at department, project team, or senior management meetings.
Lead inter‑department projects involving other contributors.
Qualifications / Skills
Ph.D. in Statistics, Biostatistics, or related field with 5+ years of experience, or equivalent master’s 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 statistical methods for trial design and data analysis.
Programming skills in R and/or SAS.
Knowledge of company SOPs and business practices.
Ability to develop and deliver multi‑mode communications (written, verbal, presentations) conveying a clear understanding of the unique needs of different audiences.
Strong project management skills: manage multiple projects, adapt approach, build partnerships, solve problems, plan and prioritize work.
Leadership experience: influence and collaborate with peers, coach others, oversee and guide work of colleagues to achieve business impact.
Preferred Qualifications
Oncology experience.
Strong statistical research and simulation skills.
Location and Compensation
Hybrid work location.
Annual base salary range: $139,100 – $231,900.
Eligibility for Pfizer's Global Performance Plan (bonus target 17.5% of base) and long‑term incentive program.
Comprehensive benefits: 401(k) with matching, paid vacation, holiday and personal days, caregiver/parental and medical leave, health, prescription drug, dental and vision coverage.
EEO & Employment Eligibility Pfizer is committed to equal opportunity in employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability or veteran status. Pfizer complies with all applicable laws governing nondiscrimination and works with E‑Verify. This position requires permanent work authorization in the United States.
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Serve as 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 coordinate with programming to create table, listing and figure shells for clinical trials or ad‑hoc analyses.
Develop study randomization specifications and verification documents.
Perform sample size calculations and assess trial design operating characteristics under various assumptions.
Advise the team on efficient design to meet study objectives.
Review CRFs, edit checks, and participate in UAT of different systems.
Review dataset programming specifications, key derived variables, and statistical deliverables.
Independently derive key efficacy variables and analyses from source data.
Analyze clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of trial results to regulatory authorities and the scientific community.
Review and contribute to study and project timelines, providing high‑quality statistical deliverables in a timely manner.
Provide statistical leadership within clinical study teams.
Present at department, project team, or senior management meetings.
Lead inter‑department projects involving other contributors.
Qualifications / Skills
Ph.D. in Statistics, Biostatistics, or related field with 5+ years of experience, or equivalent master’s 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 statistical methods for trial design and data analysis.
Programming skills in R and/or SAS.
Knowledge of company SOPs and business practices.
Ability to develop and deliver multi‑mode communications (written, verbal, presentations) conveying a clear understanding of the unique needs of different audiences.
Strong project management skills: manage multiple projects, adapt approach, build partnerships, solve problems, plan and prioritize work.
Leadership experience: influence and collaborate with peers, coach others, oversee and guide work of colleagues to achieve business impact.
Preferred Qualifications
Oncology experience.
Strong statistical research and simulation skills.
Location and Compensation
Hybrid work location.
Annual base salary range: $139,100 – $231,900.
Eligibility for Pfizer's Global Performance Plan (bonus target 17.5% of base) and long‑term incentive program.
Comprehensive benefits: 401(k) with matching, paid vacation, holiday and personal days, caregiver/parental and medical leave, health, prescription drug, dental and vision coverage.
EEO & Employment Eligibility Pfizer is committed to equal opportunity in employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability or veteran status. Pfizer complies with all applicable laws governing nondiscrimination and works with E‑Verify. This position requires permanent work authorization in the United States.
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