Director, Statistical Programming
Managing projects, individual contributors (employee and contractors), and/or vendors while also developing and implementing SAS programs to efficiently produce descriptive and statistical analyses. Generating tables, listings, and graphs (TLGs) using SAS programs for pre-clinical and clinical studies in support of U.S. and international registration applications. Participating in review of CRFs, statistical analysis plan, clinical and pre-clinical study reports, abstracts, and manuscripts as needed.
- Identify, develop, and implement strategy for the improvement of productivity and standardizing of programming activities.
- Develop SAS programs to generate TLGs according to the requirements using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
- Create CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions.
- Draft and/or review data specifications for analysis datasets.
- Review deliverables (e.g., TLGs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests) for accurate and on-time delivery.
- Review CRF design, data management plan, data validation plan, and edit check specifications.
- Apply and promote good programming practices.
- Contribute to development of standard macros.
- Interact with statisticians and interdisciplinary teams on timelines and content of deliverables.
- Manage day-to-day activities of statistical programming staff.
- Participate in Human Resources activities of the department (staffing, performance management and employee development).
- A B.S., M.S., or Ph.D. degree in statistics, biostatistics, or closely related field with a minimum of 7years pharmaceutical/biotech/CRO related experience as a SAS programmer supporting clinical trials for regulatory submissions.
- Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH,and SAS/STAT.
- Good working knowledge of CDISC SDTM and ADaM models preferred.
- Previous experience managing temporary, contract and regular employees.
- Knowledge of and ability to adhere to GCP principles and relevant regulatory requirements
- An aptitude for quantitative problem solving with the capacity to troubleshoot and work independently
- Ability to follow guidelines and specifications on validation procedures and data transfer procedures
- Strong communication skills with the ability to interface at all levels; comfortable communicating workload to assist in managing priorities
Flexible; ability to adapt to changing priorities