Senior - Principal Biostatistician
Location: Fully Remote
A top partner with Pharmaceutical and Biotechnology companies is searching for multiple Biostatisticians to analyze data and statistics gathered during clinical trials and interpret conclusions for some of the top clinical trials happening today.
Roles and Responsibilities:
- Interacts with the sponsor on all aspects of the project with oversight from a senior team member.
- Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis.
- Develops statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation.
- 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
- Supports statistical analysis of a project or study in conjunction with Data Management and Statistical Programming.
- Provides data analysis and presentation methods to support clinical studies, publications and presentations.
- Understands the operations of Biostatistics and Biometrics functions and responsibilities of other functional groups.
- Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory, Clinical Pharmacology and Project Management staff to produce project deliverables and meet timelines for statistical data analysis and reporting.
- Works independently on projects and/or studies, may support multiple projects and/or studies simultaneously, as well as other tasks assigned by the supervisor
Education:
- MS degree in Statistics, Mathematics or a closely related field. Ph.D. degree in Biostatistics or equivalent is preferred
Skills Requirements:
- Total work experience to include one year 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.
