SAS Programmer

Sciens Software Technologies; Hyderabad; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Sciens Software Technologies in Hyderabad is seeking an experienced SAS Programmer to analyze and report clinical trial data in line with SAPs, CDISC standards, and regulatory requirements. You will lead end-to-end programming, mentor junior programmers, ensure data quality, and collaborate with biostatisticians, data managers, and auditors to support regulatory submissions.

This role requires 4+ years of pharma/clinical research experience and a strong knowledge of SDTM, ADaM, and Define.xml

Qualifications

• 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 (ICH guidelines, CDISC standards).
• Excellent communication and interpersonal skills for cross-functional collaboration.

Responsibilities

• Develop and validate SAS programs for analysis and reporting of clinical trial data.
• Perform data manipulation, transformation, and cleaning using SAS programming techniques.
• Lead end-to-end statistical programming activities (e.g., SDTM, ADaM, TLF).
• Review and provide input into SAPs, data management plans, and other study documents.
• Mentor junior programmers and lead a team.

Skills

SAS programming

CDISC SDTM/ADaM

Data manipulation

Leadership & mentoring

Regulatory compliance

Communication

Problem solving

Education

Bachelor's or Master's degree in statistics, computer science, or related field

Tools

SAS

EDC systems

CDMS

Job description

Primary Responsibilities

• Develop and validate SASprograms 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 SASprogramming 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 SASprograms 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 SASprogramming 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 SASprograms.
• Ensure outputs are accurate, reproducible, and meet regulatory standards

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

• Provide training and mentor juniorprogrammers.
• 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 SASprogramming 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 SASprogrammerin 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.