Job Title: Associate Director Oncology Biostatistics
Location: San Francisco Bay Area (Hybrid)
Company: Penfield Search Partners Ltd (Client: Clinical-stage Biopharma in Oncology)
Job Type: Full-time
Salary: $1 - $2 per year (Expected compensation range)
Posted: 5 days ago
Applicants: 40
Job Description:
Position Overview:
Our client, a clinical-stage biopharma company specializing in oncology, is seeking an Associate Director of Biostatistics to lead the statistical strategy, design, and analysis for clinical trials across all phases (I-III). The Associate Director will ensure statistical methodology meets project objectives, health authority guidelines, and regulatory requirements. This hybrid role is based in the San Francisco Bay Area or Philadelphia metro areas.
Key Responsibilities:
Lead and execute statistical strategies for clinical trials.
Provide technical expertise and collaborate with clinicians, data managers, biostatisticians, programmers, and medical writers.
Develop clinical protocols, review CRFs, and create statistical analysis plans (SAPs).
Manage the creation of ADaM specifications, statistical outputs (TLF shells, Table of contents), and analyze clinical trial data.
Perform study analyses, interpret results, and collaborate on interim/final reports and publications.
Oversee CROs to ensure timely, high-quality deliverables within budget.
Provide leadership in statistical methodologies and regulatory adherence.
Participate in multidisciplinary meetings and represent Biostatistics and Clinical Data Management.
Ensure the application of regulatory guidelines and the completion of clinical trials.
Qualifications:
Education and Experience:
MS/MA in a related discipline with a minimum of 9 years of relevant experience OR
PhD in a related discipline with at least 5 years of experience.
Oncology experience and familiarity with clinical trial Phases I-III highly preferred.
Experience in the Biotech/Pharmaceutical industry preferred.
Proven expertise in SAS programming.
Strong knowledge of SDTM/ADaM specifications and clinical data management.
Extensive experience in managing CROs for clinical trials.
Technical Skills:
SAS programming expertise for clinical data analysis.
Deep understanding of statistical methodology and regulatory guidelines.
Experience with clinical trial data management procedures and collaboration with multidisciplinary teams.
Working Conditions:
Hybrid role: San Francisco Bay Area or Philadelphia metro area.
Occasional travel may be required.
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