About the Role

We are looking for an experienced SAS Programmer with strong expertise in Clinical Programming, SDTM, ADaM, TLF, and Regulatory Data Analysis. This role is ideal for professionals with a background in the pharmaceutical, biotechnology, or clinical research industry who have hands-on experience supporting regulatory submissions and clinical data programming using SAS.

You will collaborate with cross-functional teams to develop, validate, and maintain SAS programs for clinical data transformation, statistical analysis, reporting, and regulatory compliance while ensuring adherence to GxP standards and industry best practices.

Key Responsibilities

• Develop, validate, and maintain SAS programs for clinical data derivation, transformation, and reporting.

• Program and support SDTM, ADaM, and TLF deliverables for regulatory submissions.

• Design and implement SAS edit checks for data validation and cleaning.

• Perform statistical analyses, data visualization, and ad-hoc reporting using SAS.

• Extract, merge, and transform clinical and laboratory datasets from multiple data sources.

• Generate CMC eCTD data tables while ensuring compliance with regulatory and company standards.

• Collaborate with Data Management Leads and cross-functional stakeholders to gather and translate business requirements.

• Maintain complete documentation for SAS programs and validation activities.

• Manage multiple projects and deliver high-quality outputs within defined timelines.

• Escalate project risks and issues proactively.

• Ensure compliance with SOPs, GMP, GxP regulations, and ALCOA principles.

• Participate in team meetings, knowledge sharing, and continuous improvement initiatives.

Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Data Science, Physical Sciences, or a related discipline.

• SAS Certification is mandatory.

• Strong understanding of the pharmaceutical, biotechnology, or clinical research industry.

• Excellent analytical, problem-solving, and communication skills.

• Ability to work independently and collaboratively in a cross-functional environment.

Benefits

• Opportunity to work on global clinical research and regulatory submission projects.

• Exposure to advanced clinical data programming and analytics.

• Collaborative work environment with career growth opportunities.

• Competitive compensation based on experience.

Eligibility (Non-Negotiable)

• 6–10 years of full-time SAS Programming experience is mandatory.

• Minimum 6 years of hands-on experience with SDTM, ADaM, and TLF programming is required.

• SAS Certification is mandatory.

• Strong experience in clinical programming within the pharmaceutical, biotechnology, or CRO industry is required.

• Working knowledge of GxP, GMP, ALCOA principles, and regulatory submission standards is mandatory.

• Candidates must be willing to work from Mumbai, Bangalore, or Pune.

• PAN and Date of Birth (DOB) are mandatory for profile creation.

• Your CV should clearly highlight your SAS programming experience, SDTM, ADaM, TLF expertise, clinical domain experience, certifications, and regulatory project exposure. Profiles meeting the mandatory requirements will be prioritized for screening.

Apply now by sharing your updated CV along with your Current Location, Current CTC, Expected CTC, Notice Period, PAN, and Date of Birth (DOB).