Sr. SAS Programmer

Responsibilities

• To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required).
• To ensure timely and accurate programming and validation activities for clinical studies and publications.
• To contribute to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
• To 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 the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
• To access and convert data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).
• To work with external vendors in order to develop or monitor the content and structure of SAS data sets.
• To work closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
• To provide input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management.
• To provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
• To maintain standards for programming activities.
• To bring in new ideas to improve the programming process.

Requirements

• A minimum of bachelor's degree in 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, MS Office.
• Proven experience with CDISC data standards, e.g. SDTM and ADaM.
• 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.
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment.