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Pfizer · 2 hours ago

Associate Director, Biostatistics

Pennsylvania, United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$135K/yr - $225K/yr

5+ years exp

Pfizer is a leading pharmaceutical company, and they are seeking an Associate Director of Biostatistics. The role involves serving as a study statistician for clinical studies, providing statistical input for study designs, and contributing to clinical publications and regulatory submissions.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

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 clinical study team setting

May independently present at department, project team, or Sr. Management meetings

May lead inter-department projects involving other contributors

Qualification

Ph.D. in StatisticsFDA/EMA regulationsStatistical methodsProgramming in R/SASOncology experienceCDISC standardsClinical trial designMulti-mode communicationsProject managementCollaboration skills

Required

Demonstrated high aptitude (considered a subject matter expert internally) in key areas of responsibility, which is typically associated with a Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a 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

High aptitude in ICH GCP guidelines

High aptitude in Drug development process

High aptitude in CDISC standards and implementation guides

High aptitude in Statistical methods and applications to clinical trial design and data analysis

High aptitude in Programming skills in R and/or SAS

High aptitude in Company SOPs and business practices

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

Demonstrated ability to manage multiple projects

Demonstrated ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm

Demonstrated ability to consistently achieve results, even under tough circumstances

Demonstrated ability to adapt approach and demeanor in real time to match the shifting demands of different situations

Demonstrated ability to build partnerships and work collaboratively with others to meet shared objectives

Demonstrated ability to make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems

Demonstrated ability to plan and prioritize work to meet commitments aligned with organizational goals

Preferred

Oncology experience

Strong statistical research and simulation skills and experience

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact