Description
Director, Statistical ProgrammingBiometrics | South San Francisco, CA, United States
As the Director of Statistical Programming, among other responsibilities, the position holder will manage managers, projects on product levels, individual contributors (employee and consultants), and vendors. They will also be responsible for managing projects while also developing and implementing SAS programs to efficiently produce descriptive and statistical analyses.
This is a full-time and on site opportunity at a Biopharmaceutical firm in the East Bay of San Francisco.
Further Position Detail:
- Identify, develop, and implement strategy for the improvement of productivity and standardizing of programming activities
- Ensure consistency in infrastructure within the Statistical Computing organization.
- Manage department quality requirements in coordination with Regulatory Compliance and IT.
- Collaborate with functional management across the organization on project deliverables and timelines for projects within area of responsibility.
- Establish and drive program level functional strategy for resourcing, processes, and standards related to safety support for clinical development projects.
- Directly contribute to technical infrastructure of the statistical computing environment; and process improvement.
- Manage group of internal programmers, consultant programmers, and CROs; collaborate with other Biometrics functions for all activities related to analyses of clinical trial data.
- Responsible for execution of ad hoc requests, manuscripts, and presentations.
- Oversee all programming support activities for a clinical program in line with acceptable statistical methodology, timely and accurate data integration, analysis and interpretation of results.
- Oversee the preparation and review of programming deliverables for clinical study reports and scientific presentations; participate in team review of documents.
Position Requirements:
- A minimum of 12 years of SAS programming experience in the pharmaceutical or biotechnology industry with a BA/BS, or MA/MS with 10 years of experience.
- Experience in the management of people and projects
- Experience in working in and contributing to cross-functional teams
- Proven track record in forming and managing a functional team to support multiple projects.
- Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment.
- Experience with Clinical Study Reports and NDA submissions.