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Statistical Programmer Ii

Novotech
NovoTech
1-2 years
Not Disclosed
India
10 March 19, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.