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Principal Stat Programmer

0-2 years
Not Disclosed
10 March 24, 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

Description

Principal Statistical Programmer
Syneos Health® is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. We simplify and streamline processes to make Syneos Health easier to work with and for.

Join us in either a Functional Service Provider partnership or a Full-Service environment, where you will collaborate with problem solvers and innovate to help customers achieve their goals.

Why Syneos Health:

  • Passionate about developing people through career progression, technical training, and peer recognition.

  • Committed to a Total Self culture where authenticity and inclusion are prioritized.

  • Dedicated to fostering a work environment where diversity of thought and perspectives create a sense of belonging.

Job Responsibilities:

  • Use SAS or other software to develop custom programming code for 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.

  • Maintain well-organized and up-to-date project documentation ensuring inspection readiness.

  • Manage multiple projects with time constraints, adapting to timeline changes.

  • Develop specifications for datasets and outputs, addressing potential programming issues efficiently.

  • Conduct internal meetings, distribute relevant information, and ensure follow-through on action items.

  • Lead statistical programming activities, monitor progress, and provide risk mitigation plans.

  • Review project documentation such as Statistical Analysis Plan, mock shells, and programming specifications.

  • Participate in sponsor meetings and bid defense meetings when required.

  • Mentor programming personnel through training, feedback, and process guidance.

  • Maintain expertise in clinical drug development, industry standards, and regulatory submission requirements.

  • Develop programming tools and macros for efficiency and standardization.

  • Serve as a subject matter expert for CDISC and industry standards, ensuring compliance and providing training.

  • Transfer deliverables and perform other assigned duties.

  • Minimal travel may be required.

Qualifications:

  • Undergraduate degree in a scientific or statistical discipline or equivalent combination of education and programming experience.

  • Extensive programming experience in SAS or similar software, preferably in a clinical trial environment.

  • Knowledge and experience with CDISC Standards and regulatory agency submission requirements.

  • Experience mentoring others in clinical trial processes and CDISC Standards.

  • Excellent written and verbal communication skills.

  • Ability to read, write, and understand English.

Additional Information:

  • Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign additional responsibilities.

  • Equivalent experience, skills, and education will be considered where applicable.

  • Compliance with the Americans with Disabilities Act and other applicable regulations is ensured.