About the role
A global IT services, consulting, and business solutions organization focused on the healthcare and life sciences industry. The organization works with leading healthcare enterprises to build technology-driven solutions that improve efficiency, effectiveness, and accessibility across the healthcare ecosystem.
With a strong focus on healthcare technology, digital transformation, advanced analytics, and next-generation solutions, the organization enables clients to address complex healthcare challenges through technology and human expertise.
About the Role
As a Technical Lead – SAS Business Intelligence & Analytics, you will be part of an Agile team responsible for developing healthcare applications, implementing new features, and delivering high-quality clinical programming solutions while following established development and quality standards.
Responsibilities
Develop and maintain SAS programs for creation of SDTM, ADaM datasets, and Tables, Listings, and Figures (TLFs).
Validate analysis datasets, outputs, and programming deliverables to ensure accuracy and quality.
Support electronic submission (e-submission) preparation, review, and regulatory compliance activities.
Review Statistical Analysis Plans (SAPs), Data Management Plans, and other study documents to assess programming requirements and impacts.
Collaborate with cross-functional teams including Biostatistics, Data Management, Clinical Operations, and Regulatory Affairs.
Interact with external vendors for standards implementation, data transfers, and deliverable management.
Produce and maintain Define.xml, metadata documentation, and submission-ready datasets.
Ensure programming deliverables comply with CDISC standards and regulatory requirements.
Perform upstream data review and handling activities involving eDC and SDTM datasets.
Identify opportunities for process improvement, automation, consistency, and operational efficiency.
Independently manage programming assignments and deliver high-quality outputs within defined timelines.
Support regulatory submissions such as NDA, BLA, and MAA filings.
Experience
5 – 7 Years
Location
Pune
Chennai
Mumbai
Bangalore
Hyderabad
Educational Qualifications
Engineering or relevant degree – BE / ME / BTech / MTech / BSc / MSc
Technical certification in multiple technologies is desirable.
Mandatory Technical Skills
Minimum 8 years of Clinical SAS Programming experience within the pharmaceutical, biotechnology, or CRO industry.
Proficiency in SAS programming for clinical trial data analysis and reporting.
Extensive experience developing SDTM and ADaM datasets.
Hands-on experience generating Tables, Listings, and Figures (TLFs).
Strong understanding of CDISC standards, including SDTM and ADaM.
Expertise in relational databases and clinical trial data structures.
Experience with upstream clinical data handling, including eDC and SDTM data review.
Hands-on experience creating Define.xml and submission-ready deliverables.
Knowledge of regulatory submission requirements and industry standards.
Experience with Pinnacle 21, XML, and Microsoft Office applications.
Good to Have Skills
10+ years of Clinical/Statistical Programming experience.
Experience supporting regulatory filings including NDA, BLA, and MAA submissions.
Knowledge of clinical endpoints, medical terminology, and regulatory guidelines.
Experience in R programming for statistical analysis and reporting.
Exposure to Linux/Unix operating systems and programming environments.
Experience in process automation and programming efficiency initiatives.
Familiarity with emerging technologies and advanced analytics in clinical research.
Experience mentoring junior programmers and leading programming projects.
Strong communication and stakeholder management skills.
Why Join?
You will have the opportunity to work on challenging healthcare and life sciences technology initiatives, collaborate with experienced global teams, and contribute to solutions that address complex healthcare challenges.
The organization promotes a collaborative and learning-oriented work environment with opportunities for professional growth, continuous learning, and exposure to next-generation healthcare technologies.
Career & Work Culture
The organization focuses on building highly motivated engineering and technology teams with an entrepreneurial mindset. The culture emphasizes:
Passion
Respect
Openness
Unity
Depth of Knowledge
Continuous Learning
Professional Growth
Work-Life Balance
Opportunity
This is an opportunity to work with global healthcare and life sciences clients, contribute to large-scale clinical technology initiatives, and play a key role in delivering high-quality SAS programming and clinical data solutions.
Apply now and take the next step in your healthcare technology career.