Statistical Programmer | CDISC |Pune | Clinical Trials | Clinical SAS

About the Role

We're hiring an experienced Statistical Programmer with expertise in Clinical SAS Programming, CDISC Standards, ADaM, SDTM, Tables, Listings & Figures (TLF/TFL), Clinical Data Analysis, and Regulatory Submissions. This opportunity is ideal for professionals with experience supporting clinical trials, drug development, biostatistics, and pharmaceutical research while developing high-quality programming deliverables for global studies.

Candidates with experience in SAS, R Programming, Clinical Data Management, Oncology, Immunology, Neuroscience, Regulatory Filings, and Clinical Development are highly encouraged to apply.

Key Responsibilities

• Develop and validate ADaM datasets, Tables, Listings & Figures (TFLs), and statistical outputs using SAS.

• Lead statistical programming activities for assigned compounds, studies, therapeutic areas, or indications.

• Ensure compliance with CDISC standards, regulatory requirements, and company programming standards.

• Support regulatory submissions by preparing reviewer guides, define.xml documentation, and related deliverables.

• Collaborate with Biostatistics, Clinical Data Management, Medical Writing, Clinical Operations, and Regulatory teams.

• Develop and maintain reusable SAS macros, utilities, and programming standards.

• Review programming deliverables to ensure quality, consistency, and timely completion.

• Estimate programming effort, manage timelines, and support project planning activities.

• Mentor junior statistical programmers and provide technical guidance across projects.

• Participate in process improvements and contribute to statistical programming best practices.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Statistics, Biostatistics, or a related discipline.

• Minimum 2+ years of experience in Clinical SAS Programming.

• Strong expertise in SAS Programming, ADaM, SDTM, CDISC Standards, and TFL Programming.

• Experience supporting clinical trials, drug development, and regulatory submissions.

• Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience, or related clinical domains is preferred.

• Experience with R Programming is an added advantage.

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

Benefits

• Opportunity to work on global clinical research and pharmaceutical development programs.

• Exposure to end-to-end clinical trial programming and regulatory submissions.

• Career growth in a leading technology and life sciences organization.

• Competitive salary package ranging from ₹9–20 LPA.

Eligibility (Non-Negotiable)

• Minimum 2+ years of hands-on experience in Clinical SAS Programming is mandatory.

• Strong expertise in SAS, CDISC Standards, ADaM, SDTM, and TFL Programming is required.

• Experience supporting clinical trials, regulatory submissions, and drug development is highly preferred.

• Graduation is mandatory.

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

• Your CV should clearly highlight your SAS programming, CDISC, ADaM, TFL, and clinical trial experience. Profiles that do not meet the mandatory requirements may not be considered for review.

Apply now by sharing your updated CV along with your PAN, Date of Birth, Current CTC, Expected CTC, Notice Period, and Job ID 406724.

Note: Candidate profiles will be evaluated against the mandatory skills, and a profile match percentage will be shared during the screening process.