Director, Statistical Programming
1 month ago
Director of Statistical Programming - Permanent - San Francisco Bay, CA
Proclinical is seeking a Director of Statistical Programming to join a pioneering company that is developing groundbreaking therapies.
Primary Responsibilities:
This role is instrumental in shaping the future of data analysis and regulatory submissions across a diverse and expanding portfolio. The successful candidate will have the opportunity to build and lead a high-performing team, develop strategic programming standards and ensure the successful execution of regulatory submissions.
Skills & Requirements:
Sc./B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or a related field (MS preferred).Extensive experience with FDA/EMEA submissions and demonstrated communication skills.Proven project management experience in statistical programming within clinical development.Experience managing statistical programming projects delivered by CROs. The Director of Statistical Programming's responsibilities will be:Lead the development of a world-class statistical programming team.Collaborate with the Biometrics leadership team to establish operational processes and standards.Mentor and guide current statistical programming staff.Manage internal and external programming resources.Oversee the evaluation of CDISC electronic data packages.Stay updated with regulatory requirements related to CDISC and clinical programming standards.Provide consulting support to internal audit teams.Work with the Head of Biometrics to design and implement solutions for hosting clinical data and programs.Manage the statistical programming infrastructure.Develop and refine SAS macros and tools for efficient program reuse.Oversee business relationships and manage budgets with statistical programming vendors. If you are having difficulty in applying or if you have any questions, please contact Jennifer Iantosca at (+1) orProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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