Director/Senior Director, Biostatistical Programming
The Director / Senior Director, Biostatistical Programming, is responsible for the timely delivery of statistical tables, listings, and graphs from the analysis of clinical study data, as well as for submission of analysis datasets and accompanying documentation at a quality and in a format that is acceptable to the FDA.
- Supervise and direct managers who in turn have direct reports
- Take leadership in developing automated processes to improve quality and efficiency of the department
- Build or maintain excellent working relationships with statisticians, Data Management, Information Technology, and Medical Writing
- Assist the VP of statistics and programming in developing and implementing quality procedures of creating analysis datasets and producing statistical tables
- Assist VP in the projection of resource needs
- Keep abreast of industry and regulatory developments, in particular in the area of data standardization (CDISC, SDTM, ADAM) and develop or in-license efficient tools for meeting those standards.
- Masters degree in statistics, computer sciences, or related area; or Bachelor’s degree with commensurate experience.
- A minimum of 10 years experience in the pharmaceutical or biotechnology industries with extensive knowledge of biostatistics, FDA/EMEA guidelines and drug development.
- Strong technical background with experience in building programming infrastructure
- At least 3 years of directly managing people.
Incyte Corporation - 2 years ago