Director, Biostatistics
Location: Fully Remote
Compensation: $200,000 - $225,000
The world's largest partner with Pharma and Biotech companies is searching for a Director of Biostatistics to analyze data, and interpret conclusions for some of the top clinical trials happening today.
Roles and Responsibilities:
- Contribute significantly in key and innovative ways to the analyses, including the interpretation of results and the presentation to leadership of findings.
- Reviews of vendor-supplied data and analysis as needed.
- Extensive collaboration with integrated clinical teams to design studies, develop statistical analysis plans, and draft statistical reports / manuscripts for clinical studies in all phases for FDA/MAA, as well as for other global regulatory authorities
- Exercises leadership within Biostatistics, as well as the broader Data Science and Statistics Expertise Area
- Responsible for resource planning/allocation and timeline management across their clinical development program, and recruiting, retaining, managing, and mentoring biostatisticians
- Manages internal and vendor statistical and programming support.
- Leads large and/or complex late phase clinical development program. Represents Biostatistics and the broader Data Sciences and Statistics team including Data Management and Statistical Programming on the Clinical Development Team.
- Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of studies, proposing and implementing solutions.
- Serve as the statistical representative in cross-functional teams.
- Contribute to creation/maintenance of, and provide training on, statistical topics and departmental SOPs, work instructions, etc.
- Drive strategy for improved processes, contributing to new departmental SOPs, work instructions, and provide training on statistical topics and departmental SOPs, work instructions.
- Ensure consistency and adherence to standards across compounds and/or therapeutic areas
- Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversees the work of others who assist in programming/validating
- Perform protocol development, sample size calculation, protocol and CRF review, and advise data management on database design and critical data
- Provides data analysis and presentation methods to support clinical studies, publications and presentations
Education:
- Ph.D. degree in Biostatistics or equivalent is preferred
Skills Requirements:
- Total work experience to include five - ten years in CRO, Pharma, or Biotech
- Ability to synthesize results in graphic, oral, and written reports.
- Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
- Experience with statistical methods commonly used in the analysis of clinical trial data.
- Experience with SAS Base and SAS Stat, as well as strong data step skills.
- Experience with other statistical software packages, such as N-Query, S-Plus.
