Associate Director, Biostatistics

Responsibilities

• Serve as the statistical lead for assigned clinical development programs and/or clinical trials, providing leadership from protocol development through database lock, analysis, clinical study report, and regulatory submission.
• Provide statistical input into clinical development strategy, including development of study design and sample size, endpoints selection, estimands, analytic methods, and missing-data strategies.
• Develop and/or review protocols, Statistical Analysis Plans (SAPs), TLF shells, statistical programming specifications, and other statistical documents.
• Lead and/or oversee statistical analyses and interpretation of clinical trial data.
• Support the development of publications based on clinical trial data.
• Serve as the statistical representative on cross-functional study and program teams and act as a trusted statistical partner to Clinical Development and other functional leaders.
• Provide statistical expertise and leadership for regulatory submissions, briefing documents, responses to regulatory questions, and health authority interactions.
• Serve as the statistical representative on cross-functional study and program teams and act as a trusted statistical partner to Clinical Development and other functional leaders.
• Provide oversight of CRO statistical deliverables, timelines, quality, and resource requirements.
• Ensure appropriate implementation of statistical methodology per SAP requirements and quality of statistical analysis.
• Contribute to development and implementation of statistical standards, templates, processes, and best practices.
• Support the growth and development of the Biostatistics function and contribute to hiring and team development as appropriate

Qualifications

• PhD or MS degree in Biostatistics, Statistics, Mathematics, or a closely related quantitative discipline.
• 5+ years of relevant industry experience with a PhD or 8+ years with an MS, preferably within the pharmaceutical or biotechnology industry.
• Demonstrated experience providing statistical leadership for clinical trials and/or clinical development programs.
• Experience with NDA/BLA preparation and regulatory submissions is preferred.
• Strong knowledge of clinical trial design, statistical methodology, and regulatory principles.
• Hands-on experience with SAS and/or other statistical softwares and the ability to critically evaluate statistical programming outputs.
• Excellent written and verbal communication skills.
• Demonstrated ability to work independently and effectively in a fast-paced, resource-conscious biotech environment.
• Ability to manage multiple projects and priorities while maintaining high-quality deliverables.

Pay

The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.