Director, Statistical Programming

Employment Type: Full Time

Experience: 10 years or more

Full-Time Salary Range: $125,000 to $155,000

Job Description: Ensure that resources are well planned and appropriately allocated to all assigned projects based on staff availability, skills, and timelines. Develop relationships within Biostatistics and across Clinical Data Management functions such that business needs are satisfied. Stay abreast of current regulatory environment focusing on submission standards. Ensure that appropriate hardware and software are available to support all statistical programming activities by identifying new technologies which offer opportunities to improve business processes. Develop accurate budgets based on predicted project workload. Ensure that reporting standards are developing and followed. Hire and train highly competent staff that is capable, willing, and motivated to accomplish their responsibilities. Develop staff for current and future positions. Ensure that the business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies.

Support the Vice President. Ensure that all statistical programming processes are adequately documented. Ensure that all computer systems in the statistical programming environment are adequately validated based on FDA regulations and guidance. Make sure that all members of Statistical Programming receive appropriate performance management. Maintain/update SOPs and working procedures.

Requirements: Masters degree in Statistics, Biostatistics, Mathematics, Computer Science, or another related field. Ten (10) years experience in statistical programming and NDA preparation. Five (5) years experience managing statistical programming. Knowledge of SAS, CDISC, and a thorough knowledge of good programming practices and methodology. Good understanding of FDA regulations and guidance regarding programming and computer system validation. Strong communication skills: oral, written, and effective listening.