Director of Biostatistics
640 Galveston Drive Redwood City, CA 94063 US
Reporting to the Head of Biometrics, the Director of Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review the accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.
• Leads the development and execution of statistical aspects for complex early clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications
• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports and scientific publications
• Review of data validation checks to ensure analysis variable cleaning expectations are included
• Review of TLF Shells and TLFs
• Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for data to be included in SDTM
• Be able to code in SAS/R as needed
• Ad hoc review of displays in support of publications, Board of Directors, and Advisory Board meetings, etc.
• Provides statistically sound scientific methodology, experimental design, and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions
• Represent biostatistics function or biometrics department in cross function teams.
• Participates in establishing and maintaining policies, standards, and procedures for biostatistics activities
• Provide statistical oversight to vendors, contractors, and consultants
• Ph.D. degree in statistics and minimum 8 years of relevant industry experience (or master's degree in relevant statistics field and 9 years of clinical trial experience) in the pharmaceutical or biotech companies, or related experience or equivalent combination of training and experience
• Proven knowledge and expertise in statistics and its applications to clinical trials
• Oncology experience preferred
• Strategic thinking, team player, with ability to work successfully across functions
• Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms
• Strong programming experience, adept computer skills to create slides to describe/summarize data, and meticulous attention to accuracy/details
• Familiar with ICH guidelines, FDA, and other regulatory authority guidance
• Preferably NDA experience, including eCTD submission
175k- 220k Salary Range
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