Exel
Biostatistics Director
Alameda, CA · Director
Sponsorship not specified$188k-$267kDetected 31 days ago
StatisticsProject ManagementNegotiationClinical TrialsFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationBiostatisticsRegulatory Affairs
About the role
- Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
- Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies.
- Supervisory Responsibilities: • No supervisory responsibilities.
Responsibilities
- Work with department head to develop and implement department standards and practices.
- Direct the statistical design, conduct, and analysis of clinical trials in all phases.
- Review protocols and case report forms for soundness of trial design.
- Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
- Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
- 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.
- Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions.
- Manages timelines, deliverables and budgets of contract research organizations.
Requirements
- BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience
- Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio.
Skills
- Education/Experience:
- BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,
- MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,
- PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or;
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Experience/The Ideal for Successful Entry into Job:
- Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
- Preferably led a phase III clinical trial.
- In-depth knowledge of CDISC standards.
- Direct experience with FDA/EU Authority preferred.
- Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.
Compensation
- Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.
Benefits
- 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.