Clinical SAS programmer - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities:
- Lead programming activities and provide input on programming methodologies to support the clinical development process.
- Program and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write clear and robust specifications to describe programming needs.
- Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
- Manage CRO's programming deliverables by reviewing SDTM and ADaM specifications and datasets, and TFL shells and output in collaboration with other Prilenia colleagues.
- Ensure the quality of internal and external deliverables consistently complies with analysis and reporting standards and regulatory requirements.
- Assist in submission package planning and providing responses to inquiries from global regulatory agencies.
- Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
- Interact with other internal functions (biostatistics, clinical research and development, regulatory and medical writing).
- Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology, or a related field with at least 7 years (or bachelor's degree with at least 10 years) of SAS programming experience in Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations.
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) is required.
- Clear understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
- Well, organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
- Must be able to work under pressure, manage time, set priorities and meet deadlines.
Source : Katalyst Healthcares & Life Sciences
