Primary job role

The Sr. Statistical Programmer will develop and validate technical programming specifications and programs, and generate STDM and ADaM datasets, tables, figures, and listings. The incumbent should be able to work independently implementing and executing the programming and project standard to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.

Responsibilities

• 1. Manipulation of data to produce analysis datasets, including SDTM and ADaM datasets

• 2. Production and review of Tables, Figures and Listings (TFLs) according to statistical analysis plan

• 3. Creation and review of programming specifications and, if required, annotation of case report forms (CRFs) to CDISC standards

• 4. Feeding back data errors to client data management teams

• 5. Assisting internal management team in assessing resourcing needs for successful completion of assigned projects

• 6. Working to industry (CDISC) and client standards

Requirements:

• 1. Bachelor’s degree required, Masters in statistics, computer science, mathematics, engineering, or life science preferred.

• 2. MS with 6+, BS with 8+ years of programming experience in the bio-pharmaceutical industry

• 3. CDISC (SDTM and ADaM) experience

• 4. Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.