Lead SAS Programmer

SDTM Programming

• Develop and validate SDTM domains for assigned studies.
• Generate SDTM validation reports and Pinnacle 21 compliance outputs.
• Prepare SDTM Reviewers Guide and related support documents.

ADaM Programming

• Create analysis-ready datasets and implement dataset specifications.
• Develop ADaM validation programs and traceability documentation.
• Produce statistical tables patient listings safety figures CSR outputs and interim analysis deliverables.

Programming Quality

• Maintain programming review checklists and validation reports.
• Generate quality metrics reports and standard macro documentation.

Data Management & Reconciliation

• Prepare data review listings missing data reports and protocol deviation listings.
• Support query management metrics SAE reconciliation PK sample reconciliation and external lab reconciliation.
• Handle eCOA/Paper COA reconciliation reports.

SAS Viya Expertise

• Develop CAS-enabled clinical programs.
• Implement automated reporting workflows.
• Conduct Viya migration testing and performance optimization.

Regulatory Submission Support

• Prepare SDTM and ADaM submission packages.
• Support creation and complete CRT package assembly.

Qualifications :

Qualifications

• 10 years of clinical SAS programming experience.
• Strong expertise in SDTM and ADaM standards.
• Hands-on experience with SAS.
• Ability to work independently and lead programming deliverables.
• Experience across Phase 1 PK studies and Phases 24 in various therapeutic areas

Desired Skills

• Excellent problem-solving and analytical skills.
• Strong communication and documentation abilities.
• Ability to ensure compliance with industry standards.

Additional Information :

Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at  Work :

No

Employment Type :

Full-time