Senior SAS Clinical Trials Programmer

1 month ago

Austin, Texas, United States Della Infotech Full time
Job Title: Senior SAS Clinical Trials Programmer

Job Summary:
Della Infotech is seeking a highly skilled Senior SAS Clinical Trials Programmer to join our team. As a Senior SAS Clinical Trials Programmer, you will be responsible for developing, testing, and executing SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and listings (TFL).

Key Responsibilities:
  • Develop, test, and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and listings (TFL).
  • 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 (e.g., adaptive design, integrated safety/efficacy 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.

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.
  • Good written and spoken communications skills in English and thought-leadership skills.

What We Offer:
  • A competitive salary and benefits package.
  • The opportunity to work with a talented team of professionals in the pharmaceutical and biotech industry.
  • The chance to develop your skills and expertise in SAS programming and clinical trials.

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