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Sr Statistical Programmer(Sdtm, Adam &Tlf)

2+ 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 1, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002566

Job Description:
Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success by translating clinical, medical, and commercial insights into actionable outcomes. We focus on simplifying and streamlining processes, making it easier to work with and for Syneos Health.

At Syneos Health, you will collaborate with passionate problem-solvers, innovating as a team to help customers achieve their goals and accelerate the delivery of therapies. Our agile, customer-centered approach is driven by a shared passion for changing lives.

Why Join Syneos Health:

  • Career development and progression

  • Supportive and engaged line management

  • Technical and therapeutic area training

  • Recognition and rewards programs

  • Inclusive "Total Self" culture

Key Responsibilities:

  • Use SAS or other software to develop programming code to generate summary tables, data listings, graphs, and derived datasets as per the statistical analysis plan

  • Ensure that outputs meet quality standards and project requirements

  • Perform validation programming and resolve discrepancies with the project team

  • Keep team members informed of programming progress and emerging issues

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

  • Maintain up-to-date project documentation and ensure inspection readiness

  • Manage scheduling, time constraints, and priorities across multiple projects

  • Develop specifications for complex datasets and outputs, anticipating programming issues

  • Contribute to internal meetings, prepare ideas, and respect others’ opinions

  • Lead internal meetings, ensuring timely distribution of minutes and following up on action items

  • Display willingness to collaborate and assist with business initiatives

  • Negotiate accurate time estimates for project activities and deliverables

  • Direct programming activities of other personnel and monitor progress

  • Review project documentation (e.g., Statistical Analysis Plan, SAS database design) and provide feedback

  • Participate in sponsor and kickoff meetings as a statistical programming representative

  • Mentor junior programming personnel, develop training materials, and provide feedback

  • Transfer deliverables

  • Perform other work-related duties as assigned

  • Minimal travel may be required

Qualifications:

  • Undergraduate degree, preferably in a scientific or statistical discipline, or equivalent combination of education and experience

  • Extensive programming experience in SAS (or other required software), preferably in a clinical trial environment

  • 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:
The company reserves the right to modify tasks, duties, and responsibilities as needed. Equivalent experience, skills, and education will be considered. This role complies with all local legislation and equal opportunity guidelines.