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Associate Director of Statistics


San Francisco, CA
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Job Details

Job Title Associate Director of Statistics

JobID 1046607-1852

Location: San Francisco, CA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

This position will provide statistical support for early and late phase clinical trials in Oncology. The successful candidate will collaborate with study teams working effectively across functions (statistics, programming, data management, clinical, safety, outcomes research/health economics, clinical pharmacology, translational oncology, and medical writing) to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports and present results summarizing findings. The candidate will directly contribute to the Company success by increasing the strength of study designs and associated interpretability of results, and by implementing continuous improvement practices in all areas of research that involve statistical analysis of data.


*Ensures high-quality statistical support is provided for assigned studies and associated regulatory submissions and uses state-of-the-art statistical methods*Provides rigorous statistical input into study protocols including development of study objectives and design, patient selection strategies based on molecular profiling or genotyping, and statistical methodology taking into consideration all applicable health authority guidelines. *Reviews and checks treatment allocations in randomized clinical studies and ensures proper implementation*Monitors the quality of clinical trials data *Complies with all Pfizer processes *Complies with all statistics and quality processes and Pfizer data standards that are applicable to statistical methodology, data collection and reporting and supports processes that require statistical input. *Develops statistical analysis plans, provides input into data presentation mocks and specifications and analysis data set specifications for clinical study reports, scientific presentations and publications, submission level documents (including summary of clinical safety, summary of clinical efficacy and risk management plan), responses to health authorities and labeling negotiations as they pertain to the assigned studies. Authors the topline report for assigned studies. Uses statistical judgment to inform the merits of exploratory analyses*Provides statistical input and leadership to cross-functional activities; collaborate with other statisticians, clinicians, safety clinicians, clinical pharmacologists, translational oncologists, outcomes research/health economics, project managers, Alliance Partners (APs) including programmers, data managers, and writers for assigned studies *Maintains expertise in the field of biostatistics, and brings best practices and new methodologies in-house *Helps maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learning across units, divisions and locations. *Writes and validates statistical applications as required*Participates in professional development activities both within and outside the company


*MS with 4 years experience or Ph.D. in biostatistics, statistics or related field*At least 4 years' experience in application of statistical methods in research including experience and broad knowledge of major statistical techniques, in particular Survival analysis, Linear and Non-linear modeling, Bayesian Statistics and experimental design*Proficiency in statistical software packages such as SAS, R or S-PLUS*Proficiency and clarity in both written and oral communications is essential*Familiarity with basic terminology and methods used in conducting oncology clinical trials and research.*Must possess organizational skills and be able to work independently and support multiple studies in a project team environment.*Ability to manage multiple tasks concurrently*Preference will be given to the candidates with Oncology clinical trials experience specifically with knowledge and experience in oncology trial designs, analysis of biomarker data and, patient selection strategies based on molecular profiling or genotyping and NDA submissions.PHYSICAL/MENTAL REQUIREMENTS:*Ability to perform mathematical calculations *Ability to perform complex data analysisNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:Ability to travel to attend meetings with health authorities

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Associate Director of Statistics*
*San Francisco, California*

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