Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Programming Lead

Fortrea
Fortrea
5+ years
Not Disclosed
Bangalore, India
10 May 7, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Programming Lead – Statistical Programming (Clinical Trials)
Experience: ~5 Years
Employment Type: Full-Time
Work Mode: Office or Home (as per manager approval)
Location: Bangalore
Application Deadline: May 31, 2026
Job Requisition ID: 261995


Job Overview

This role is for a Lead Statistical Programmer responsible for overseeing end-to-end programming activities for clinical studies.

You will lead study-level programming deliverables, ensure compliance with timelines and quality standards, manage resources, and coordinate with cross-functional teams and clients.

The role also includes mentoring junior programmers and contributing to process improvement initiatives.


Key Responsibilities

1. Study Leadership & Planning

  • Act as Lead Statistical Programmer for clinical studies

  • Plan and manage:

    • Programming activities

    • Resource allocation

    • Budget adherence

    • Study timelines

    • Quality standards

  • Coordinate with internal teams and clients


2. SAS Programming & Deliverables

  • Develop and maintain SAS programs for:

    • SDTM datasets

    • ADaM datasets

    • Tables, Listings, and Figures (TFLs)

  • Perform QC of:

    • SDTM datasets

    • ADaM datasets

    • TFL outputs


3. Clinical Data Standards & Submissions

  • Ensure compliance with CDISC standards

  • Develop specifications for SDTM and ADaM datasets

  • Produce regulatory submission documents including:

    • Define XML/PDF files

    • Analysis Results Metadata (ARM)

    • Annotated CRFs

    • Review Guides


4. Review & Audit Support

  • Review Statistical Analysis Plans (SAPs)

  • Review TFL shells from programming perspective

  • Respond to:

    • QA audits

    • Client audits

    • Qualification audits (with support when needed)


5. Mentoring & Knowledge Sharing

  • Mentor junior and less-experienced programmers

  • Share knowledge in departmental meetings

  • Support skill development within the programming team


6. Process Improvement

  • Identify opportunities to improve:

    • Productivity

    • Quality

    • Efficiency in programming processes

  • Contribute to standardization and best practices


7. Collaboration & Communication

  • Work closely with:

    • Cross-functional clinical teams

    • Clients

    • Internal programming teams

  • Ensure smooth communication of technical deliverables


Required Qualifications

  • Bachelor’s degree in:

    • Mathematics

    • Statistics

    • Computer Science

    • Life Sciences

    • Health Sciences

    • Or related field

OR

  • Equivalent education and relevant experience


Experience Required

  • Minimum 5 years of SAS programming experience

  • Experience in:

    • CRO or Pharmaceutical industry

  • Strong knowledge of CDISC standards (SDTM, ADaM)

  • Equivalent experience + education may be considered


Skills Required

  • Strong SAS programming expertise

  • Deep understanding of clinical data standards (CDISC)

  • Ability to manage study-level deliverables independently

  • Strong leadership and mentoring ability

  • Excellent communication and coordination skills

  • Strong analytical and problem-solving skills

  • Ability to handle audits and client interactions


Language Requirements

  • English (Required):

    • Speaking

    • Writing

    • Reading


Work Environment

  • Office or remote (as per manager approval)

  • Global clinical trial programming environment

  • Client-facing responsibilities

  • Occasional travel (~5%, including client meetings and training)


Travel Requirements

  • Local, Domestic, Regional travel

  • Approximately 5% travel

  • May include overnight stays