Senior SAS Clinical Trials Programmer

2 months ago


Austin, Texas, United States Della Infotech Full time
Job Title

Senior SAS Clinical Trials Programmer

About the Role

We are seeking a highly skilled Senior SAS Clinical Trials Programmer to join our team at Della Infotech. As a key member of our clinical trials programming team, you will be responsible for leading the development of SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and listings.

Key Responsibilities
  • Develop, test, and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and listings.
  • Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures, and listings (TFL) shells.
  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells, and other specifications, e.g., patient profiles, OPS reports.
  • Serve as a programming project lead on a complex study to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively.
  • Manage the study documentation flow as per Worldwide SOP and other procedural documentation, including timely document submission to eTMF.
  • Contribute to department process improvement, including creating and testing standard SAS Macros, maintaining the required validation documentation.
  • Provide consultancy to Clinical Data Managers, Statistical Programmers, and Biostatisticians on programming, clinical, and analysis data standards (CDISC) and electronic data submission requirements.
  • Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure, and tools, collaboration with other internal and external parties, and the role of the statistical programmer.
Requirements
  • Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc., Healthcare or technology-related field.
  • 8+ years of SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry.
  • SAS certifications (Base, Advanced, etc.) are highly desired. Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
  • Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
  • CDISC data models a necessity, especially SDTM then ADaM.
  • CDISC knowledge.
  • SDTM and ADaM dataset experience.
  • Good written and spoken communications skills in English and thought-leadership skills.
About Us

Della Infotech is a leading provider of clinical trials programming services. We are committed to delivering high-quality solutions that meet the needs of our clients. If you are a motivated and experienced Senior SAS Clinical Trials Programmer looking for a new challenge, we encourage you to apply for this exciting opportunity.



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