SAS Programmer

Primary Responsibilities

• Develop and validate SAS programs for the analysis and reporting of clinical trial data in accordance with study protocols, statistical analysis plans (SAPs), and regulatory requirements.
• Perform data manipulation, transformation, and cleaning using SAS programming techniques to ensure data quality and integrity.
• Perform end-to-end statistical programming activities (e.g., SDTM, ADaM, TLF).
• Review and provide input into statistical analysis plans, data management plans, and other study documents.
• Conduct peer review of SAS programs and output to ensure accuracy, consistency, and compliance with company standards and regulatory guidelines.
• Review complete CDISC package such a Define.xml, study RTF ect.
• Participate in study team meetings and provide programming expertise and support as needed.
• Stay current with industry trends, best practices, and regulatory requirements related to SAS programming in clinical research.
• Ability to prioritize tasks, manage multiple projects simultaneously, and meet tight deadlines.
• Lead and mentor a team of statistical programmers.
• Oversee project timelines, resource planning and deliverables.
• Develop, validate and maintain SAS programs.
• Ensure outputs are accurate, reproducible, and meet regulatory standards

(e.g., CDISC, FDA, EMA).

• Provide training and mentor junior programmers.
• Familiarity with clinical trial processes, ICH guidelines, and regulatory submission requirements.
• Participate in audits and inspections as needed.
• Manage multiple priorities in a fast-paced environment.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Collaborate with biostatisticians, clinical data managers, and other stakeholders to understand data requirements and programming specifications.
• Contribute to the creation and maintenance of standard programming macros, templates, and libraries to streamline programming processes and ensure consistency across studies.

Technical Skill Requirements

• Experience with CDISC data standards (e.g., SDTM, ADaM, TLF) and familiarity with CDISC implementation guidelines.
• Proficiency in SAS programming includes data step, PROC SQL, PROC REPORT, PROC TRANSPOSE, and macro programming.
• Experience working with electronic data capture (EDC) systems and clinical trial data management systems (CDMS) is preferred.

Qualification

• Bachelors or Master’s degree in statistics, computer science, or a related field.
• Minimum of 4+ years of experience as a SAS programmer in the pharmaceutical, biotechnology, or clinical research industry.
• Solid understanding of clinical trial processes, data structures, and regulatory requirements (e.g., ICH guidelines, CDISC standards).
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.