Genentech, Inc. seeks a Senior Statistician at its South San Francisco, CA location.
Description: Within biotechnology/pharmaceutical organization, develop and implement data-driven drug development strategies spanning all phases of clinical trials for life sciences. Lead statistical design, planning, and analysis of clinical studies and trials through application of statistical methods including group-sequential and combination-test procedures, hierarchical testing strategies for biomarker subgroups, and event-driven analysis planning. Prepare statistical methodology sections of clinical protocols, Statistical Analysis Plans, and regulatory briefing materials. Monitor statistical integrity, adequacy, and accuracy in clinical studies settings within assigned therapeutic area. Prepare Independent Data Monitoring Committee (IDMC) and Integrated Management Committee (IMC) charters, defining statistical decision rules, interim-data-review processes, and safety-monitoring boundaries. Prepare, integrate, and interpret data used to support internal governance and regulatory decision-making, which includes the preparation of comprehensive efficacy, safety, and pharmacokinetic summaries to inform dose-selection and progression decisions at key governance meetings. Liaise with global health authorities and build collaborative partnerships with cross-affiliate stakeholders to support product development and related programs, processes, systems, and compliance initiatives. May telecommute 100% from any US location.
Education and experience required: Master’s degree in statistics or closely related field and 3 years of experience as statistical scientist, biostatistician or a closely related role supporting clinical trials.
Special Requirements: Full term of experience must include the following:
1. Applying principles of experimental design to plan and analyze clinical studies for diseases, ensuring appropriate control, randomization, and statistical validity, in conformance with global health authority requirements.
2. Statistical modeling and data modeling to evaluate relationships between treatment, biomarkers, and patient outcomes.
3. Applying statistical strategies for end-to-end drug development lifecycle.
4. Analyzing clinical trial data and summarizing efficacy and safety results
5. Programming for statistical analysis using R and SAS
6. Developing statistical analysis plans and study protocols
7. Preparing data summaries and reports for data monitoring.
May telecommute 100% from any US location.
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Worksite: 1 DNA Way, South San Francisco CA, 94080
The expected annual salary for this position based on the primary location for this position of South San Francisco, California is $151,560 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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