88-50100047 Senior Statistician

Roche•South San Francisco, CA

1d•Remote

About The Position

Within a 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.

Requirements

Master’s degree in statistics or closely related field
3 years of experience as statistical scientist, biostatistician or a closely related role supporting clinical trials
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.
Statistical modeling and data modeling to evaluate relationships between treatment, biomarkers, and patient outcomes.
Applying statistical strategies for end-to-end drug development lifecycle.
Analyzing clinical trial data and summarizing efficacy and safety results
Programming for statistical analysis using R and SAS
Developing statistical analysis plans and study protocols
Preparing data summaries and reports for data monitoring.

Responsibilities

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.
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, including comprehensive efficacy, safety, and pharmacokinetic summaries.
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.