Job Details

Our client is a biotech company focused on developing breakthrough therapies in Oncology. The Associate Director, Biostatistics will be a statistical expert supporting the clinical development of both early and late-stage programs The ideal candidate will have a strong background in oncology and substantial experience in Biostatistics within the biotech or pharmaceutical industry. This job will be hybrid on site in the client's San Francisco Bay Area office.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis and reporting of clinicals
• Partner with Clinical Development, Regulatory, Pharmacovigilance, Quality Assurance, Commercial organizations on design and execution of clinical trials in the client's portfolio.
• Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE. Participate in writing regulatory documents (briefing documents, safety summary, efficacy summary)
• Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
• Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROs.
• Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
• Partner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness.
• Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of studies, proposing and implementing solutions.
• Ensure consistency and adherence to standards across compounds and/or therapeutic areas.
• Performs other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• PhD in Statistics, Biostatistics, or Mathematics
• 5+ years of experience in clinical trials and pharmaceutical industry
• Demonstrated ability for project management of competing priorities in clinical development
• Experience managing delivery of statistical projects by CROs
• Extensive hands-on experience in oncology drug development including design and analysis of early and late phase oncology trials
• Demonstrated ability to apply complex statistical methods, conduct and interpret the results
• Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research
• Excellent project management, interpersonal and communication skills
• Ability to influence and to contribute to the advancement of innovative statistical methodology
• Strong demonstrated interest in statistical research activities and application of novel methods to clinical trial development.
• Knowledge of missing data handling, multiple comparisons, survival analyses techniques and simulation techniques.
• Experience in organizing and driving regulatory submissions such as NDA, sNDA, and MAA submissions.
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Ability to learn, be proactive, motivated, and consistently focused on details and project execution
• Proficiency with statistical programming in SAS (including SAS/STAT, SAS/GRAPH, SAS/MACRO) and R.
• Proficiency with sample size calculations software
• Familiarity with CDISC SDTM and ADaM specifications and associated regulatory guidance
• Excellent analytical, oral and written communication and organizational skills