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Principal Stat Programmer (Adam, Tlf's , Sdtm)

2+ years
Not Disclosed
10 Nov. 29, 2024
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

Company: Syneos Health
Location: Global


About Syneos Health

Syneos Health is a premier biopharmaceutical solutions organization dedicated to accelerating innovation in clinical development, medical affairs, and commercial services. Partnering with industry leaders, the company drives results in a highly dynamic environment, delivering therapies to patients faster.


Job Summary

The Principal Statistical Programmer plays a critical role in designing and executing statistical programming tasks for clinical trials. As a subject matter expert, the Principal Programmer ensures compliance with regulatory standards, mentors team members, and leads multiple complex projects.


Responsibilities

Programming and Data Management:

  • Develop custom SAS programs to generate datasets, tables, listings, and graphs per statistical analysis plans.
  • Validate and troubleshoot discrepancies in outputs, ensuring adherence to project timelines.
  • Maintain comprehensive project documentation and quality control materials for inspection readiness.

Leadership and Collaboration:

  • Act as the lead programmer, overseeing and directing programming activities of the team.
  • Review and provide feedback on statistical analysis plans, mock shells, annotated CRFs, and programming specifications.
  • Conduct effective internal meetings, distribute actionable insights, and maintain focus on deliverables.

Compliance and Standards:

  • Ensure all deliverables align with CDISC and other industry standards.
  • Serve as a technical expert for SDTM, ADaM, and DEFINE.XML requirements for regulatory submissions.
  • Regularly update the team on changes in industry standards and participate in industry forums.

Mentorship and Training:

  • Provide training and guidance to team members on clinical trial processes, programming, and CDISC standards.
  • Develop and present technical training materials and mentor junior programmers.

Innovation and Process Improvement:

  • Proactively identify and implement programming tools and macros to enhance standardization and efficiency.
  • Evaluate existing processes and recommend improvements to meet evolving industry and client needs.

Qualifications

Required Skills and Experience:

  • Education: Undergraduate degree in scientific or statistical discipline preferred, or equivalent experience.
  • Experience: Extensive SAS programming experience, particularly in clinical trials, with demonstrated leadership in global or complex projects.
  • Expertise in CDISC standards and familiarity with regulatory agency requirements.
  • Proven experience mentoring and training team members.
  • Strong analytical, organizational, and communication skills.

Preferred Skills:

  • Experience with submissions to regulatory agencies.
  • Strong understanding of clinical drug development processes.
  • Excellent written and verbal communication in English.

Why Syneos Health?

  • Global Impact: Partnered on 94% of FDA-approved drugs and 95% of EMA-authorized products over the past five years.
  • Inclusive Culture: Embrace diversity in thought and background, fostering a collaborative and supportive environment.
  • Career Development: Extensive opportunities for learning, training, and advancement in a competitive, dynamic industry.

Additional Information

  • Travel: Minimal travel may be required.
  • Flexibility: Tasks and responsibilities may evolve as determined by the company.

How to Apply

If you are a programming expert with a passion for clinical development and regulatory compliance, join Syneos Health and contribute to life-changing work. Apply today or connect with the Talent Network to stay informed about future opportunities.

Syneos Health values diversity and encourages applicants from all backgrounds to apply. Transferable skills will be considered.