Reporting to the Head of Biostatistics, the Senior Director / Executive Director of Biostatistics acts as statistical lead with accountability for one or more therapeutic the company’s products and study deliverables; Provides strategic input in advancing clinical programs; Offers technical leadership and biostatistical support on the design and implementation of clinical studies; Leads regulatory interactions and submissions to the FDA and other regulatory agencies as biostatistics lead; Coordinates the effort across the different programs to identify, develop and implement departmental standards, applications, processes and training.
Work Model :
Flex: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager
Responsibilities:
• Ph.D. in Statistics or Biostatistics with 13 years (minimum 15 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
• Led in NDA/BLA/MAA activities from statistics perspective and experienced in direct regulatory interaction and regulatory inspections
• Contribute in study level tasks from statistics perspective, including but not limiting to: contribute in study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
• Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute to the supporting projects from statistics perspective
• Work collaboratively within biometrics teams and with teams to meet product timelines for statistical data reporting
• Translate statistical thinking into strategic input to improve the clinical program
• Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project goals and regulatory statistical and data requirements
• Lead in developing department standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications
• Oversee work by CRO and ensure quality deliverables
Requirements:
• Experience as product lead statistician and contribute in strategy discussion in cross functional settings; Experienced in managing multiple products and studies
• Experience in study level work including authoring SAP and TFL specification
• Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance
• Experience with mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, CRM, adaptive design)
• Excellent communication and interpersonal skills, with the ability to translate statistical concept to program strategies
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies
The following are some highlighted benefits, but not limited to:
• Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
• Long-term Incentive and Employee Stock Purchase Plans
• Paid parental, adoption, and caregiver leave
• Wellness Offering
• Deferred compensation for specific roles
• Fitness reimbursement
• Tuition Reimbursement
• Professional development programs
Location: California
Posted: Sept. 22, 2024, 5:39 a.m.
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