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) 917-475-4588 or j.iantosca@proclinical.com.
Proclinical 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.
