Senior Manager, Clinical Statistics - La Jolla, CA | Biospace
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Senior Manager, Clinical Statistics

Pfizer Inc.

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Location:
La Jolla, CA
Posted Date:
9/22/2017
Position Type:
Full time
Job Code:
1614235
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

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

Requirements

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.

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