Director of Biostatistics
16 hours ago
insitro is seeking a highly skilled Director of Biostatistics to lead our clinical trial biostatistics efforts. As a key member of our team, you will be responsible for developing and executing our biostatistics strategy, directly impacting the overall success of our clinical programs.
Key Responsibilities- Clinical Trial Design: Develop and implement biostatistical strategies and analysis plans to support the development of multiple therapeutics and diagnostics in interventional clinical trials.
- Clinical Trial Execution: Provide statistical input for safety review, dose escalation, and efficacy evaluation, as well as oversight of data collection and analysis.
- Clinical Study Documentation: Create statistical components of all clinical study-related documents.
- Cross-Functional Collaboration: Establish and maintain biostatistics standards, processes, and best practices, including statistics SOPs, GCP, and software tools.
- Statistical Programming: Lead and manage statistical programming activities, provide hands-on programming support for clinical studies, and oversee programming work by CROs/FSPs.
- Management: Serve as biostatistics lead for the initial clinical-stage asset(s) and help build and manage a focused, effective team of biostatisticians.
- Collaboration: Collaborate effectively with cross-functional teams on programming strategies, including specifications, analysis datasets, and analysis outputs.
- Education: Ph.D. or equivalent in statistics, biostatistics, or a related field.
- Experience: 5+ years of experience in statistical programming in the pharmaceutical or biotechnology industry, including experience in clinical trial data analysis and reporting.
- Skills: Proficiency in frequentist and Bayesian biostatistical approaches, experience with frequentist and Bayesian dose escalation designs, and strong proficiency in statistical programming languages, such as SAS or R.
- Leadership: Ability to work independently as well as lead statistics teams, with strong communication and collaboration skills.
insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. We rely on extensive biological and computational infrastructure to advance novel targets and patient biomarkers, design therapeutics, and inform clinical strategy.
Since launching in 2018, insitro has raised over $700 million from top tech, biotech, and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit our website.
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