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Senior Manager, Clinical Statistics

Pfizer


Location:
San Diego, CA
Date:
11/02/2017
2017-11-022017-12-12
Pfizer
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Job Details

This position will provide statistical support for a number of early to late phase clinical trials in Oncology. The successful candidate will collaborate with study teams working effectively within the clinical tetrad (clinician, clinical pharmacologist, translational oncologist and statistician) 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 Company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing continuous improvement practices in all areas of research that involve statistical analysis of data.







**ROLE RESPONSIBILITIES**



Ensure high-quality statistical support is provided for assigned studies conducted at Pfizer Oncology through the use of state-of-the-art statistical methods



Provide scientifically rigorous statistical input into study design, study protocol, patient selection strategies based on molecular profiling or genotyping, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects



Review protocols to ensure that objectives are met and Pfizer standards are maintained



Review and check treatment allocations in randomized clinical studies and ensure proper implementation



Monitor the quality of clinical trials data



Ensure compliance with process & quality of deliverables within the development program



Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.



Provide statistical input and leadership to cross-functional activities - collaborate with other statisticians, project managers, programmers, study managers, and writers, etc. for assigned projects



Comply with all statistics and quality processes and Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.



Maintain expertise in the field of biostatistics, and bring best practices and new methodologies in house



Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations and learning across units, divisions and locations.



Write and validate statistical applications, as required



Author or contribute to reports and/or scientific presentations



Participate in professional development activities both within and outside the company







**QUALIFICATIONS**



MS with 8+ years' or Ph.D., with 5+ years' experience in biostatistics, statistics or related field



At least 5 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 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.







Additional Details:



Eligible for employee referral bonus.



Grade 13







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.







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.







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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