Exel
Executive Director, Biostatistics
Alameda, CA · Director
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About the role
- Understands at a deep level clinical trials principles and norms.
- Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
- The base pay range for this position is $271,000 - $385,000 annually.
Responsibilities
- Provide technical oversight of the statistical design, conduct, and analysis of clinical trials in all phases.
- Review protocols and case report forms for soundness of trial design.
- Direct analysis, interpret study results, and collaborate with study team to deliver interim reports, final reports, safety updates and publications.
- Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
- Management and statistical analysis of data obtained from Phase I - IV clinical studies in support of NDAs.
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.
- Build strong relationships both within and outside biostatistics
- Leads the biostatistics function in developing statistical strategy, design, and analyses for conducting clinical trials in all phases for multiple compounds.
- Develops and/or applies statistical theories, methods, and software.
- Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Requirements
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 16 years of related experience
- PhD in Statistics/Biostatistics or related discipline and a minimum of 15 years of related experience
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Nice to have
- Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years.
- Supervision of multiple statisticians required.
- Has led phase 1-4 (preferably phase 3) oncology studies.
- Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
- In-depth knowledge of CDISC standards.
- Direct experience with FDA/EU Authority preferred.
Skills
- Strong people management and interpersonal skills
- Strong communication skills
- Strong conflict management skills
- Developed/reviewed SDTM/ADaM specifications.
- Excellent knowledge of FDA/EU/ICH statistical guidelines.
- Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs, and drug safety.
- Project management and contract negotiation with outside vendors.
- Develops technical and/or business solutions to complex problems.
- Applies strong analytical and business communication skills.
- Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
- Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
- Education/Experience:
Compensation
- The base pay range for this position is $271,000 - $385,000 annually.
Benefits
- Provide vision and direction for the development and implementation of department standards and practices.
- Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.