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Sr Statistical Programmer(Sdtm, Adam &Tlf)

0-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Remote 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

 

Job Title:

Senior Statistical Programmer (SDTM, ADAM & TLF)


Company:

Syneos Health


Location:

India-Asia Pacific - Home-Based, India


Job ID:

25002566


Job Type:

Full-Time


Role Overview:

The Senior Statistical Programmer is responsible for using SAS or other software to develop custom programming code for generating summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan. This position requires extensive programming experience, particularly in clinical trial environments, and will involve leading programming activities, mentoring junior staff, and ensuring project deadlines and quality standards are met.


Key Responsibilities:

  1. Programming & Development:

    • Develop custom programming code using SAS (or other software) to generate summary tables, listings, graphs, and datasets per the statistical analysis plan.

    • Ensure the outputs meet quality standards and project requirements.

  2. Collaboration & Problem Solving:

    • Work with other programmers, biostatisticians, and project team members to resolve programming discrepancies.

    • Act as the lead statistical programmer, directing the activities of other programming personnel.

  3. Documentation & Compliance:

    • Maintain complete, organized, and up-to-date project documentation and verification/quality control documents.

    • Follow applicable SOPs, WIs, and regulatory guidelines such as ICH.

  4. Project Management:

    • Manage project timelines, ensuring the completion of programming activities within allotted timeframes.

    • Prepare for and contribute to internal and sponsor meetings, providing programming expertise.

  5. Mentorship & Training:

    • Mentor and develop junior programming personnel by providing training, feedback, and guidance.

    • Review work and provide constructive feedback to ensure quality outputs.

  6. Leadership & Teamwork:

    • Lead and direct programming activities for other personnel, monitoring progress and ensuring deliverables are met on time.

  7. Sponsor Interaction:

    • Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.


Requirements:

  • Education:

    • Undergraduate degree, preferably in a scientific or statistical discipline; or equivalent education and demonstrated programming experience.

  • Experience:

    • Extensive programming experience in SAS or other relevant software, preferably within a clinical trial environment.

  • Skills:

    • Strong written and verbal communication skills.

    • Proficiency in SDTM, ADAM, and TLF development.

    • Ability to work under pressure and manage multiple projects.

    • Ability to read, write, speak, and understand English.


Why Syneos Health?

  • Syneos Health emphasizes career development, progression, and a supportive culture.

  • The company is committed to diversity, inclusion, and the Total Self culture, where employees are encouraged to bring their authentic selves to work.