This Associate Director position will spearhead the statistical programming activities for multiple studies and will lead the programming submission related activities. Additionally, this position will work with the Head of programming to establish standards for programming and establish efficiency within the group.
Truly a great opportunity to serve as the key "go to" Subject Matter Expert for all Statistical Programming issues in a highly specialized yet collegial corporate environment where as Associate Director, Statistical Programming, you have an integral role in driving the success of our key projects and deliverables.
Significant areas of oversight include SAS programming activities in support of Multiple Studies (Phase I) for a single or multiple compounds within related therapeutic areas spanning inception through to submission.
Ideally, candidate should possess TA experience in epilepsy, Neurodegenerative disease, sleep disorders, Alzheimer's disease, cardio vascular or inflammatory disease.
* MS in relevant field and 8+ years of statistical programming experience required.
* CDISC experience with FDA and PMDA as well as proven project management skills
* Submission, ISS, and Client expertise.
* Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes.
* Extensive experience with Phase I trials is essential.
* Solid leadership skills, including management of people resources, FTEs, Contractors, and/or CRO vendors within a matrixed environment.
* Experience in clinical development statistical programming methods and processes in industry setting required.
* Experience in multiple therapeutic areas is desired, Neurology strong preferred.
* NONMEM data set creation expertise is a plus.
Source: Job Diva – Job Listing