Location:
United States
Job Posted Date:
October 22, 2021
Opportunities:
Full-time Positions
Population:
Other
Roles and Responsibilities of the Position
- Lead the biostatistics function to develop and execute statistical strategy, design and analyses for clinical pharmacology trials across portfolio.
- Ensure the use of appropriate statistical methodologies and its clear communication in a cross functional setting.
- Oversee and collaborate with statistical analysis vendors and consultants as needed.
- Maintain transparent communication with vendors and partners enabling timely and quality deliverables.
- Provide support and instructions for derivations and analyses for clinical pharmacology studies to statistical programming as appropriate to ensure quality of deliverables.
- Develop statistical programs as necessary to perform analyses, prepare data displays and verify the correctness of data and analyses.
- Help design data capture methods and select appropriate study endpoints for clinical pharmacology studies.
- Contribute to establishing and maintaining policies, procedures, and standards within the biostatistics department and in cross functional teams as appropriate.
Job Requirements:
Required Qualifications and Background
- PhD with minimum 8 years OR master’s with minimum 10 years of experience in statistics/biostatistics/related field is required
- Minimum 3 years of clinical pharmacology studies experience in the pharmaceutical/biotech industry is required
- Strong knowledge of clinical trial design, drug development regulations pertinent to statistical analysis, and sound understanding of statistical applications for clinical pharmacology studies is required
- Familiarity with common PK modelling approaches is preferred (although implementation is not part of the responsibilities) and can be part of training
- Previous NDA/BLA/MAA experience is preferred.
- Proficient SAS programming skills and solid understanding of CDISC models and standards
- Ability to plan, develop timelines, multi-task, and shift priorities rapidly to meet tight deadlines.
- Excellent writing and communication skills along with demonstrated leadership abilities and excellent interpersonal skills.
Available Locations for the Role
- South San Francisco, CA
- US Based-Remote
Location:
National