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Sr Statistical Programmer(Sdtm, Adam &Tlf)

5+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Statistical Programmer (SDTM, ADAM & TLF)
Updated: April 9, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002567

Job Description:
Syneos Health® is a leading biopharmaceutical solutions organization committed to accelerating customer success. We bring patients and customers to the center of everything we do, with a focus on simplifying and streamlining our work. Syneos Health offers an agile environment where we work passionately to change lives.

Why Join Syneos Health:

  • Career development and progression opportunities

  • Supportive line management

  • Technical and therapeutic area training

  • Recognition and rewards programs

  • Inclusive "Total Self" culture

Key Responsibilities:

  • Develop custom programming code (SAS, etc.) to generate summary tables, data listings, graphs, and derived datasets

  • Ensure outputs meet quality standards and project requirements

  • Perform validation programming and resolve discrepancies with team members

  • Keep team members informed of programming progress and issues

  • Adhere to SOPs, WIs, and regulatory guidelines (e.g., ICH)

  • Maintain organized project documentation and ensure inspection readiness

  • Manage multiple projects, prioritize tasks, and adjust schedules as necessary

  • Develop specifications for datasets and outputs according to sponsor requirements

  • Prepare for and contribute to internal meetings, ensuring effective communication

  • Lead programming activities, mentor team members, and track progress

  • Review project documentation and provide feedback to improve efficiency

  • Represent statistical programming in sponsor meetings

  • Mentor junior programming personnel through training and feedback

  • Perform other duties as assigned

  • Minimal travel may be required

Qualifications:

  • Undergraduate degree (preferably in a scientific or statistical field) or equivalent experience

  • 5+ years of Clinical SAS Programming experience

  • Strong expertise in Base SAS, SAS/Macros, SDTM, ADAM, and TLF generation

  • Experience with R and GitLab is a plus

  • Clinical domain knowledge and SDTM experience is preferred

  • Excellent written and verbal communication skills

  • Proficient in English

About Syneos Health:

  • Worked with 94% of all Novel FDA Approved Drugs in the past 5 years

  • Supported 95% of EMA Authorized Products

  • Involved in 200+ studies across 73,000 sites and 675,000+ trial patients

Note:
Responsibilities may evolve, and the company may assign other tasks as necessary. Qualifications may differ based on equivalent experience and skills. This is in compliance with local employment legislation and equal opportunity guidelines.