Senior Statistical Programmer II (Remote)

Role Summary

Senior Statistical Programmer II (Remote) provides technical guidance on clinical project teams, focusing on design, development, and quality control of SAS programs to access, extract, transform, review, analyze, and submit clinical data for individual studies. Participates in departmental and cross-functional technology development and process improvement initiatives.

Responsibilities

• Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM format
• Performs quality control checks of SAS code and output produced by other Statistical Programmers
• Demonstrates proficient knowledge of clinical development and medical data
• Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision
• Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications
• Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry
• Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary time line constraints while assuring high quality standards

Qualifications

• Required: Competence with SAS; Working knowledge of CDISC Standards; Working knowledge of clinical trials; Effective communication (written and verbal) skills to exchange complex information with others
• Preferred: None specified

Skills

• SAS proficiency
• CDISC Standards knowledge
• Clinical trial domain understanding
• Strong written and verbal communication

Education

• Bachelor's/Master's degree in a Scientific Discipline
• Experience: Typically requires 2+ years for MS or above, and 5+ years for BS, of work experience in Biotech, Pharmaceuticals or Clinical Research Organization