Director Biostatistics Oncology

Director of Biostatistics, Oncology

(Hybrid work environment - Brisbane, CA 3 days per week)

Position Overview:

As the Director of Biostatistics, you will work closely with cross-functional teams to provide statistical expertise for multiple clinical trials. You will play a key role in trial design, execution, and statistical oversight, ensuring alignment with corporate and departmental objectives. In this role, you will collaborate with external partners, CROs, and internal stakeholders to meet project deliverables, timelines, and regulatory requirements.

Key Responsibilities:

• Serve as the primary study statistician for clinical trials, offering high-quality decision support through trial design and statistical analyses.
• Represent the Biostatistics function on cross-functional product development teams and contribute to the clinical development strategy.
• Evaluate and implement innovative trial designs and novel statistical methodologies for clinical studies.
• Oversee all statistical-related activities outsourced to CROs and external vendors, working collaboratively with Clinical Research, Drug Safety, Regulatory, and Project Management teams to meet deadlines.
• Ensure adherence to regulatory requirements and statistical principles in all clinical trial-related activities.
• Work with internal and external stakeholders to conduct statistical analyses, support trial publications, and prepare regulatory submission documents.
• Review data collection strategies, database designs, and analysis plans, ensuring statistical validity and regulatory compliance.
• Lead the preparation of Statistical Analysis Plans (SAPs) and oversee the creation of tables, listings, and figures (TLFs).
• Conduct exploratory analyses, sample size computations, and develop models for data insights.
• Present statistical findings and considerations to internal teams, senior management, and global health authorities.
• Stay current with advancements in statistics, drug development, and regulatory guidance.

Qualifications:

• PhD in Statistics/Biostatistics or related field, with 10+ years of experience in pharmaceutical or biotechnology (non-CRO) industry.
• Extensive experience in oncology drug development, with expertise in both early and late-phase clinical trials.
• Strong experience in regulatory interactions, including FDA, EMA, PMDA, and regulatory submissions (eCTD, NDA/BLA).
• Thorough understanding of GCPs and experience in a quality-regulated environment.
• Proficient in SAS and R programming.
• Familiarity with industry data standards such as CDISC, SDTM, and ADaM.
• Demonstrated ability to work cross-functionally as a strategic partner in drug development.
• Excellent communication and negotiation skills, with strong time management abilities.
• Strong critical thinking and problem-solving skills.
• Experience working with external vendors and managing outsourced statistical functions.

Additional Information:

• Travel may be required up to 15%.