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Principal Stat Programmer

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

Principal Statistical Programmer
Updated: March 20, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002387

Job Description:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into real-world outcomes. We are committed to putting the customer and the patient at the center of everything we do. With a focus on simplifying and streamlining our processes, we ensure that Syneos Health is both easy to work with and for.

As a Principal Statistical Programmer, you will be part of a collaborative team, utilizing your programming expertise to manage complex statistical programming deliverables while contributing to the development of cutting-edge therapies.

Why Join Syneos Health:

  • Focus on career development and progression

  • Supportive and engaged line management

  • Opportunities for training in technical and therapeutic areas

  • Peer recognition and comprehensive rewards programs

  • A culture where diversity, authenticity, and inclusion are at the core

Key Responsibilities:

  • Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets based on the statistical analysis plan

  • Ensure quality outputs meet project requirements and industry standards

  • Perform validation programming and work closely with other programmers, biostatisticians, and project team members to resolve discrepancies

  • Maintain well-organized, up-to-date project documentation, testing, and quality control documents

  • Develop specifications for datasets and outputs, anticipating programming issues and ensuring accurate variable definitions

  • Conduct effective internal meetings, ensuring proper distribution of information, and tracking action items

  • Manage multiple programming deliverables concurrently, proactively informing management of timelines, risks, and resolutions

  • Lead programming activities, mentoring junior team members, and providing training on complex programming topics

  • Review project documentation and provide feedback to improve programming efficiency

  • Represent statistical programming in sponsor meetings, kickoff meetings, and bid defense meetings

  • Contribute to the development of standard operating procedures (SOPs), guidelines, and tools to improve efficiency

  • Act as a subject matter expert for CDISC and other regulatory requirements, ensuring compliance and providing training to relevant teams

  • Participate in industry standards organizations and keep the Biometrics Department updated on changes

Qualifications:

  • Undergraduate degree in a scientific or statistical discipline, or equivalent experience

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

  • Knowledge and experience with CDISC Standards and regulatory agency submissions

  • Ability to mentor others in clinical trial processes and CDISC Standards

  • Strong written and verbal communication skills

  • Proficiency in English, both spoken and written

About Syneos Health:

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

  • Supported 95% of EMA Authorized Products

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

Additional Information:
The company reserves the right to assign other duties and responsibilities as needed. Qualifications may differ based on experience, and the company is committed to compliance with all applicable laws and regulations.