Sr. SAS Programmer

Senior SAS Programmer

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• Support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors as required, ensuring timely and accurate programming and validation activities for clinical studies and publications.
• Contribute to the overall efficiency and best practice of the Biostatistics group, demonstrating effective work within a clinical team environment.
• Provide statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary, and coordinating programming activities among the study programmers to achieve timely progress in areas such as SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
• Access and convert data to SAS from database management system and PC file formats (e.g., MS Excel, text files).
• Work with external vendors to develop or monitor content and structure of SAS data sets.
• Collaborate closely with clinicians, statisticians, and publication managers to generate and QC outputs for publications; review publication abstracts/manuscripts to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activity metrics for management review.
• Provide input to Database and CRF Development, creating edit check programs and providing feedback to Data Management.
• Provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
• Maintain standards for programming activities.
• Work independently to accomplish tasks and goals defined by supervisor.
• Bring in new ideas to improve the programming process.

• Minimum of a bachelor's degree in a related science discipline.
• Minimum 7+ years’ experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• Experience using SAS‑Base, MACRO, STAT, GRAPH, ACCESS, and MS Office.
• Experience in CDISC data standards, e.g., SDTM and ADaM.
• Proven experience with Unix and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues.
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment.

Mid‑Senior level

Contract

Information Technology

Pharmaceutical Manufacturing