Exel
Sr Director, Biostatistics
Alameda, CA · Director
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About the role
- Understands at a deep level clinical trials principles for early development, translational medicine strategy and clinical biomarker strategy.
- Applies sound statistical methodology to meet key project objectives related to early development including clinical biomarker and translational medicine objectives.
- Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
Responsibilities
- Provide technical oversight of the statistical design, conduct, and analysis of early phase clinical trials.
- Review protocols for soundness of trial design.
- Lead and directly manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, costs, methods, and resourcing.
- 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
- Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials.
- Sets direction for statistical support of translational medicine and clinical biomarkers.
- Develops and/or applies statistical theories, methods, and software.
- Partners in early clinical development program study design, biomarker strategy and translational medicine strategy establishing standards for clinical conduct, and the collection, management and/or reporting of data.
- Recruits, develops, and supervises project statisticians.
Requirements
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 13 years of related experience
- PhD in Statistics/Biostatistics or related discipline and a minimum of 12 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.
- Experience working with and analyzing clinical biomarker and large genetics and omics datasets
- Experience managing multiple statisticians.
- Has led phase 1 and phase 2 oncology studies.
- Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
- Knowledge of CDISC standards.
- Experience interacting directly with FDA and/or EU Authorities preferred.
Skills
- Strong people management and interpersonal skills
- Strong communication skills
- Strong conflict management skills
- Excellent knowledge of FDA/EU/ICH statistical guidelines.
- 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.
- Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
- Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
- Education/Experience:
Compensation
- Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.
Benefits
- Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.