Associate Director, Statistical Programming
Integrated Resources Inc
Associate Director, Statistical Programming
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 II -IIIB) 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, and sleep disorders, cardio vascular or inflammatory disease.
Qualifications
CDISC expertise is a must
• Submission, ISS, and ISE expertise
• Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
• Solid leadership skills, including management of people resources, FTEs, Contractors, and/or CRO vendors within a matrixed environment.
• Experience in multiple TA is desired, Neurology strong preferred.
• Experience in clinical development statistical programming methods and processes in industry setting required. MS in relevant field and 8+ years of statistical programming experience or equivalent.
Vacancy posted 3 days ago
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