Clinical Data Programmer I (SDTM)

Novotech; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Novotech is seeking a Clinical Programmer (SDTM) to lead SDTM programming across clinical protocols, eCRF and analysis plans. You will collaborate with biostatisticians and programmers to deliver quality SDTM outputs and prepare submission-ready datasets and documents.

The role requires 1–2 years’ SDTM programming experience, SAS proficiency, and familiarity with CDISC SDTM and SDTMIG standards. Applicants should have a life sciences or quantitative background and a careful, detail-focused

Qualifications

• Bachelor’s degree in life sciences, CS, math, statistics or related field.
• Experience with SDTM concepts and regulatory data standards.

Responsibilities

• SDTM Programming and annotation of SDTM CRF.
• Program and validate data sets from raw data to SDTM data.
• SDTM Quality Control, Double Programming and Peer Review.
• Develop Define.xml datasets, Reviewers Guides, and regulatory submission documents.
• Adhere to programming standards and ensure traceability of SAS programs.

Skills

SDTM Programming

SAS

CDISC SDTM

R

Attention to detail

Education

Bachelor’s Degree in Life Sciences/CS/Math/Stats

Tools

SAS

R

Job description

About the Role

The Clinical Programmer (SDTM) is primarily responsible for SDTM programming based on Clinical Protocols, eCRF and Statistical Analysis Plans. The Clinical Programmer (SDTM) may also be responsible for data submission packages to clients and regulators. The Clinical Programmer (SDTM) works collaboratively with the project biostatisticians, Statistical Programmers and other project stakeholders to produce quality SDTM outputs based on the eCRF design, clinical protocol and Statistical Analysis Plan.

Responsibilities

• SDTM Programming and annotation of SDTM CRF.
• Program and validate data sets from raw data to SDTM data.
• SDTM Quality Control, Double Programming and Peer Review.
• Develop Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.
• Adhere to company statistical programming standards, conventions, and data standards.
• Ensure that SAS programs are properly documented and traceable.
• SAS data set validation by using pinnacle 21.
• Maintain study documentation, programs and files within project files.
• Maintain timesheets.

Experience and Qualifications

• Bachelor's Degree in Life Sciences, Computer Science, Mathematics, Statistics, or Quantitative/Analytical fields.
• SDTM Programming
• Clinical Protocols and Statistical Analysis Plans
• Organizational Skills

Experiences

• Experience in Pharmaceutical industry, CRO or related experience.
• 1-2 years of programming experience specifically in SDTM concepts.
• Proficiency in SAS: SAS is widely used for SDTM dataset creation and validation
• Knowledge of CDISC standards: Understanding SDTM, SDTMIG, and controlled terminology is essential
• Programming in R: Tools like allow SDTM dataset creation in R, offering modular and reusable algorithms for automation
• Attention to detail: Ensuring data integrity and compliance with regulatory requirements.
• Clinical trial knowledge: Familiarity with study protocols, lab data, and adverse event reporting.
• Certification in SAS is recommended.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.