Statistical Programmer II – SAS | Clinical Trials & Biostatistics
Location: India
Company: Novotech
Employment Type: Full-Time
Job Overview
Novotech is seeking a skilled and detail-oriented Statistical Programmer II to support statistical programming activities across global clinical trials. This role involves developing high-quality datasets, tables, figures, and listings (TFLs) while ensuring compliance with regulatory standards and internal SOPs. The Statistical Programmer II will collaborate closely with biostatisticians and cross-functional teams, contribute to study deliverables, and mentor junior programmers.
Key Responsibilities
Clinical Study Programming
Review clinical study protocols to identify statistical programming requirements
Estimate programming timelines and contribute to resource planning and risk mitigation strategies
Develop and maintain SDTM and ADaM dataset specifications
Program SDTM, ADaM datasets, and generate Tables, Figures, and Listings (TFLs) as per approved specifications
Ensure all outputs comply with CDISC standards and regulatory requirements
Perform peer review of datasets and specifications developed by junior programmers
Maintain complete documentation for programs, datasets, and outputs to ensure traceability
Project Execution & Compliance
Adhere to company programming standards, conventions, and SOPs
Ensure timely delivery of high-quality programming outputs for assigned studies
Maintain accurate project documentation and timesheets
Support audit readiness and regulatory inspections
Collaboration & Mentorship
Work closely with biostatisticians, data managers, and clinical teams
Provide technical guidance and mentorship to junior statistical programmers
Participate in cross-functional meetings including Biostatistics and Biometrics discussions
Tools & Process Improvement
Contribute to the development of SAS macros and programming standards
Support continuous improvement initiatives in statistical programming processes
Ensure efficient utilization of programming tools and automation techniques
Required Qualifications
Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related quantitative field
OR
Bachelor’s degree in a relevant field with additional experience
Strong knowledge of SAS programming in clinical trials
Solid understanding of CDISC standards (SDTM, ADaM)
Good understanding of clinical trial design and data structures
Strong analytical, problem-solving, and communication skills
Experience Required
Master’s degree holders: Minimum 1 year of relevant experience in statistical programming
Bachelor’s degree holders: Minimum 2 years of experience in pharmaceutical, CRO, or clinical research industry
Hands-on experience in SAS programming for clinical studies and dataset generation
Key Skills
SAS Programming
CDISC (SDTM & ADaM Standards)
Clinical Data Analysis & Reporting
TFL Development (Tables, Figures, Listings)
Regulatory Compliance & Documentation
Problem-Solving & Analytical Thinking
Team Collaboration & Mentorship
Why Join Novotech?
Be part of a globally recognized CRO delivering innovative clinical research solutions
Work on international clinical trials with advanced statistical methodologies
Inclusive and collaborative work culture
Flexible work environment with strong employee benefits
Continuous learning, mentorship, and career advancement opportunities
About Novotech
Novotech is a leading global full-service Contract Research Organization (CRO), providing clinical development and scientific advisory services to pharmaceutical, biotechnology, and medical device companies. With a strong presence across Asia-Pacific, the United States, and Europe, Novotech is committed to accelerating innovation and improving patient outcomes worldwide.
How to Apply
Apply through Novotech’s official careers portal or submit your updated resume via ThePharmaDaily.com to explore global opportunities in statistical programming and clinical research.
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