Statistical Data Analyst
4 weeks ago
**Lead Biostatistics and Programming Activities**
The Principal Biostatistician will be responsible for leading the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization.
Key responsibilities include planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget, to required quality.
Regulatory interaction experience is also preferred.
- Review project database structures, edit checks, and data management coding conventions.
- Preparation of statistical analysis plans, including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.
- Statistical analysis, interpretation of data, and reporting of results.
- Writing of the statistical methods sections of integrated study reports.
- Supports responses to regulatory questions on the design of the program, and any labeling claims following submission.
- Preparation of biostatistics input to company research proposals and participates in proposal defense meetings and makes presentations at marketing meetings with prospective clients.
A D. degree in statistics, biostatistics, or a related field is required, along with experience in statistics, biostatistics, or a related field.
Key qualifications include knowledge of clinical trials methodology, regulatory requirements, statistics, and statistical software packages, including SAS.
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