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Principal Stat Programmer

0-2 years
Not Disclosed
10 April 7, 2025
Job Description
Job Type: 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:

Principal Statistical Programmer

Company:

Syneos Health®


Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization that combines clinical development, medical affairs, and commercial capabilities. With over 29,000 employees in 110 countries, it is focused on accelerating customer success by delivering modern, integrated, and data-driven healthcare solutions.


Why Syneos Health:

  • Strong commitment to career development and progression

  • Supportive line management

  • Training in technical and therapeutic areas

  • Peer recognition and rewards programs

  • Inclusive “Total Self” culture

  • Diverse and global workplace


Job Responsibilities:

  • Use SAS or other software to program summary tables, data listings, graphs, and datasets

  • Ensure output quality and adherence to project requirements

  • Perform validation programming and resolve discrepancies with the project team

  • Keep the team updated on programming status and issues

  • Follow relevant SOPs, WIs, and regulatory guidelines (e.g., ICH)

  • Maintain complete and inspection-ready documentation

  • Manage priorities across multiple projects; reorganize workload as needed

  • Develop specifications for datasets/outputs; anticipate and resolve programming issues

  • Lead internal meetings and ensure clear communication and follow-through

  • Lead statistical programming activities and monitor junior programmers

  • Review project documentation (e.g., SAP, CRFs, mock shells) and provide feedback

  • Represent programming in sponsor/kickoff/bid defense meetings

  • Mentor junior programming personnel; develop and present training materials

  • Serve as a technical expert on CDISC and other industry standards

  • Conduct compliance reviews of deliverables (e.g., SDTM, ADaM, DEFINE.XML)

  • Participate in industry standards organizations and share updates with the department

  • Transfer deliverables as needed

  • Perform other related duties

  • Minimal travel required


Qualifications:

  • Undergraduate degree (scientific or statistical discipline preferred), or equivalent education/experience

  • Extensive SAS programming experience in a clinical trial environment

  • Demonstrated ability to lead global and complex projects

  • Strong knowledge of CDISC standards and regulatory submission requirements

  • Experience mentoring others on CDISC and clinical trial processes

  • Excellent written and verbal communication skills

  • Fluent in English


Additional Information:

  • Duties and responsibilities may change based on business needs

  • Equivalent skills or education may be considered

  • This is not an employment contract

  • Compliant with ADA and EU Equality Directive

  • Reasonable accommodations will be provided when appropriate