Senior Manager, Clinical Statistics
Location:
San Diego , California
Posted:
October 23, 2017
Reference:
716599632

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. 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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