Role Summary
Senior Director of Biostatistics, reporting to the VP of Biostatistics, responsible for leading the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. Collaborates cross-functionally to support planning, execution, and analysis of the trial, applying advanced statistical methods for clinical trial design and data analysis. Based in San Francisco, CA or Cambridge, MA with minimal travel (~10%). Responsibilities
Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment. Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation. Develop and author key statistical documents. Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions. Provide statistical input for CSRs, IBs, DSURs, and other study-level and submission documents. Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards. Manage CRO statistical activities, including DMC deliverables, to ensure high-quality execution. Manage and mentor junior statisticians as applicable. Provide statistical leadership across multiple projects with overlapping timelines, as needed. Qualifications
Required: 10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics. Required: Minimum of 3 years direct leadership experience. Required: Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies. Required: Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions. Required: Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE). Required: Demonstrated ability to manage CROs in the conduct and analysis of clinical trials. Required: Proven ability to represent Biostatistics effectively in multidisciplinary meetings. Required: Strong history of effective collaboration across cross-functional teams. Preferred: Strong understanding of regulatory requirements, industry standards, and guidance documents. Preferred: Broad and thorough knowledge of statistical principles and clinical trial methodology, with expertise in oncology study design and analysis. Preferred: Comprehensive understanding of RECIST 1.1 guidelines. Preferred: Expertise in CDISC standards, including SDTM and ADaM. Preferred: Proficiency in SAS and/or R programming. Preferred: Ability to develop innovative and creative statistical and technical solutions to complex problems. Preferred: Excellent verbal and written communication skills. Preferred: Impeccable professional ethics, integrity, and judgment. Education
PhD in Statistics or Biostatistics.
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Senior Director of Biostatistics, reporting to the VP of Biostatistics, responsible for leading the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. Collaborates cross-functionally to support planning, execution, and analysis of the trial, applying advanced statistical methods for clinical trial design and data analysis. Based in San Francisco, CA or Cambridge, MA with minimal travel (~10%). Responsibilities
Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment. Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation. Develop and author key statistical documents. Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions. Provide statistical input for CSRs, IBs, DSURs, and other study-level and submission documents. Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards. Manage CRO statistical activities, including DMC deliverables, to ensure high-quality execution. Manage and mentor junior statisticians as applicable. Provide statistical leadership across multiple projects with overlapping timelines, as needed. Qualifications
Required: 10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics. Required: Minimum of 3 years direct leadership experience. Required: Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies. Required: Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions. Required: Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE). Required: Demonstrated ability to manage CROs in the conduct and analysis of clinical trials. Required: Proven ability to represent Biostatistics effectively in multidisciplinary meetings. Required: Strong history of effective collaboration across cross-functional teams. Preferred: Strong understanding of regulatory requirements, industry standards, and guidance documents. Preferred: Broad and thorough knowledge of statistical principles and clinical trial methodology, with expertise in oncology study design and analysis. Preferred: Comprehensive understanding of RECIST 1.1 guidelines. Preferred: Expertise in CDISC standards, including SDTM and ADaM. Preferred: Proficiency in SAS and/or R programming. Preferred: Ability to develop innovative and creative statistical and technical solutions to complex problems. Preferred: Excellent verbal and written communication skills. Preferred: Impeccable professional ethics, integrity, and judgment. Education
PhD in Statistics or Biostatistics.
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