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 workplace.

- 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.

📌 SAS Programmer (Hyderabad)
🏢 Sciens Software Technologies
📍 Hyderabad