Manager, Statistical Programming

Overview

Manage statistical programming activities supporting clinical studies and regulatory submissions. The role focuses on SAS/R programming, CDISC-compliant datasets, TFLs, validation, and technical guidance.

What you'll do

• Develop and validate SDTM and ADaM datasets.
• Program and quality-check efficacy and safety TFLs.
• Perform statistical programming in SAS and R.
• Review, debug, and validate programming code.
• Collaborate with Biostatistics, Data Management, Clinical, and other teams.
• Maintain programming documentation, specifications, macros, and templates.
• Provide technical guidance to junior programmers or peers.

What you'll need

• 7+ years of relevant clinical statistics experience in industry.
• Bachelor’s or master’s degree in a related field such as Statistics, Data Science, computational biology, bioinformatics, or computer science.
• Strong SAS programming experience in CDISC-compliant clinical programming.
• Strong knowledge of SDTMIG and ADaMIG standards.
• Experience developing efficacy and safety TFLs.
• Understanding of clinical trial design, data structures, analysis, and regulatory requirements.
• Strong problem-solving, organizational, communication, and detail-orientation skills.

Nice to have

• Experience working remotely with international teams.
• Experience with Define.xml, SDRG, ADRG, P21 reports, ISS, or ISE deliverables.
• Statistical background or knowledge.

Details

• Remote role in India.
• Full-time employment.