Associate Director Oncology Biostatistics

Penfield Search Partners Ltd; San Francisco (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An established industry player in the biopharmaceutical sector is seeking an experienced Associate Director of Biostatistics to lead statistical strategies for clinical trials. This hybrid role offers the opportunity to work with a dynamic team, applying advanced statistical methodologies to meet project objectives and regulatory requirements. The ideal candidate will possess extensive experience in Oncology and a strong background in SAS programming. Join a forward-thinking company dedicated to innovation in cancer treatment, where your expertise will contribute to groundbreaking advancements in healthcare.

Qualifications

• 9+ years of experience in biostatistics, especially in Oncology.
• Strong SAS programming skills and knowledge of regulatory standards.

Responsibilities

• Lead statistical strategies and analysis for clinical trials.
• Collaborate with multidisciplinary teams on clinical protocol development.

Skills

SAS Programming

Statistical Analysis

Clinical Data Management

Oncology Knowledge

Regulatory Guidelines

Effective Communication

Education

MS/MA in relevant field

PhD in relevant field

Tools

SDTM Standards

ADaM Standards

Job description

Associate Director Oncology Biostatistics

Our client, a clinical-stage biopharma company focusing on Oncology, is seeking an experienced Associate Director of Biostatistics. This role involves leading statistical strategies, design, and analysis for clinical trials across all phases. The successful candidate will apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.

Location & Role Details

This is a hybrid position based in the San Francisco Bay Area or Philadelphia metro areas.

Key Responsibilities

1. Provide technical expertise and recommendations on statistical issues, trial design, and conduct.
2. Develop and share knowledge of current statistical methods.
3. Collaborate with clinicians, data managers, biostatisticians, programmers, and medical writers.
4. Contribute to clinical protocol development.
5. Review CRFs, CRF edit checks, and guidelines.
6. Author statistical analysis plans, TLF shells, and output documentation.
7. Review ADaM specifications and verify efficacy endpoints.
8. Analyze data, interpret results, and collaborate on reports and publications.
9. Manage CROs to ensure quality and timeliness.
10. Oversee programming of ADaMs and TLFs.
11. Handle multiple studies with concurrent tasks.
12. Participate in validation and QC of study endpoints and submissions.
13. Apply regulatory guidelines appropriately.
14. Guide project teams and develop solutions to complex problems.
15. Identify methods and procedures to achieve project results.
16. Perform tasks with creativity and autonomy.

Qualifications

• MS/MA with ≥9 years or PhD with ≥5 years of related experience.
• Experience in Oncology and Phases I-III preferred.
• Industry experience in biotech/pharmaceuticals preferred.
• Experience managing CROs and with clinical data management.
• Strong SAS programming skills and knowledge of SDTM/ADaM standards.
• Understanding of regulations and industry standards.
• Effective communication skills across multidisciplinary teams.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Science