We're Hiring
- Senior / Principal Statistical Programmers ?

Location:
Hyderabad, India ? Work Mode: Remote (with occasional office visits, if required) ?

Experience:
Minimum 6+ years in Clinical Statistical Programming ? Time-Zone Requirement: 60–70% overlap with US client time zones (EST/EDT, PST/PDT), depending on project requirements. ? Apply directly through our careers page: https://www.cpvia.com/careers or share your updated CV at [email protected] Company Description: CPVIA Private Limited provides clinical data analytics, statistical programming, and biostatistics consulting services to pharmaceutical, biotechnology, and medical device companies. We work on global clinical development projects, delivering quality-driven solutions in line with industry and regulatory standards. Role Description: We are looking for experienced Senior / Principal Statistical Programmers to join our team. The role involves leading and executing statistical programming activities for clinical trials, supporting clinical study deliverables and regulatory submissions, and ensuring compliance with CDISC standards and quality requirements. The selected candidates will work closely with biostatisticians, data management teams, and global client stakeholders while contributing to high-quality clinical programming deliverables.

Key Responsibilities
• Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards.
• Generate and validate TFLs (Tables, Listings, and Figures) for clinical study reporting and regulatory submissions.
• Work on efficacy and safety programming activities, with a strong emphasis on efficacy deliverables.
• Review specifications, Statistical Analysis Plans (SAPs), and programming requirements.
• Perform independent QC, code reviews, and validation of programming deliverables.
• Support regulatory submissions, including ISS/ISE,



as applicable.
• Collaborate with biostatisticians, data managers, and global project teams.
• Manage study deliverables, timelines, and client communication. Required Qualifications & Experience
• Minimum 6+ years of hands-on experience in Statistical Programming within the clinical research / pharmaceutical domain.
• Strong proficiency in SAS programming and clinical trial data standards.
• Good hands-on experience in efficacy programming, including efficacy-related ADaM datasets and TFLs.
• Robust working knowledge of CDISC standards – SDTM and ADaM.
• Experience in developing, validating, and reviewing clinical study datasets, tables, listings, and figures.
• Good understanding of clinical trial processes, SAPs, specifications, and regulatory submission requirements.
• Experience across therapeutic areas such as Oncology and Immunology is preferred. Experience in Hematology, Rheumatology, Cardiovascular, or other complex therapeutic areas will also be considered.
• Experience with regulatory submissions, and submission-related deliverables is an added advantage.
• Strong analytical, problem-solving, documentation, and quality control skills.
• Ability to independently manage deliverables and coordinate with cross-functional and client teams. Work Arrangement & Time-Zone Requirements
• This is a remote-based opportunity open to candidates located in India.
• Willingness to work with approximately 60–70% overlap with US client time zones (Eastern/Pacific), depending on project requirements.
• Ability to collaborate effectively with geographically distributed client and project teams.
• Strong communication skills and flexibility to accommodate client meetings and project deliverables across time zones. ? Interested candidates can apply through https://www.cpvia.com/careers share their updated CV at [email protected].

📌 Senior/Principal Statistical Programmer (Hyderabad)
🏢 CPVIA Private
📍 Hyderabad