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Director, Clinical Statistics


San Diego, CA
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Job Details

Job Title Director, Clinical Statistics

JobID 1612648

Location: San Diego, CA

Description **ROLE SUMMARY**

This position will provide statistical support for publication activities 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 help define and implement publication strategy, design studies, develop protocols, write statistical analysis plans, perform statistical analyses, write reports, present results and summarize findings.

The candidate will directly contribute to the Company's success by increasing the strength of scientific presentations, study designs and associated interpretability of results, by contributing to publication strategy, biomarker strategies and by implementing continuous improvement practices in all areas of research that involve statistical analysis of data.


+ This incumbent will be the single statistical point of contact for publication activities, representing statistics in the associated strategy teams.

+ Is responsible for planning, coordinating and monitoring timelines and deliverables for all statistical deliverables associated with publication activities or other assigned projects.

+ Provide statistical support for study design/conduct, regulatory submissions and/or interactions with Health Authorities.

+ Provides scientifically rigorous statistical input, high-quality statistical support and uses state-of-the-art statistical methods for all assigned projects.

+ Provides rigorous statistical input into the publication strategy, identifies minimum set of analyses needed to support the publication strategy, develops statistical plans to support analyses, provides input into data presentation mocks and specifications and analysis data set specifications for scientific presentations and publications, conducts analyses, summarizes and presents results, and, as needed, for submission level documents and responses to Health Authorities. Uses statistical judgment to inform the merits of exploratory analyses.

+ Provides rigorous statistical input into the 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.

+ 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. Helps develop program specific standards for data collection and reporting.

+ Provides statistical input and leadership to cross-functional activities; collaborate or oversee deliverables from other statisticians, and collaborate with clinicians, safety clinicians, clinical pharmacologists, translational oncologists, outcomes research/health economics, project managers, programmers, data managers, and writers for assigned projects.

+ 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 or Ph.D. in biostatistics, statistics or related field.

+ At least 10 (for MS) or 7 (for PhD) years of experience and broad knowledge of major statistical techniques, in particular Survival analysis, Linear and Non-linear modeling, Bayesian Statistics and experimental design, and application in research.

+ Proficiency in statistical software packages such as SAS, R or S-PLUS.

+ Proficiency and clarity in both written and oral communications.

+ Must possess organizational skills and be able to work independently and in a team environment. Experience coordinating and overseeing deliverables from other statisticians at a project level.

+ Experience in providing statistical leadership to cross-functional teams at the project level.

+ Preference will be given to the candidates with regulatory submission experience (NDA and/or MAA) in Oncology.


+ Travel may be required to support assigned program.

**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.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Additional Offer Details:**

+ This job is Pfizer Exempt US Grade: 016

+ Additional Location Information: San Francisco, CA, Groton, CT, Collegeville, PA, Remote, Milan.

+ Eligible for Employee Referral Bonus

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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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