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Sr Principal Stat Programmer

1+ 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

Senior Principal Statistical Programmer


About Syneos Health

Syneos Health is a global biopharmaceutical solutions company, empowering innovation in clinical development and commercialization. Our teams are committed to advancing therapies and improving patient lives.

"Work Here Matters Everywhere."


Key Responsibilities

Programming Expertise

  • Provide technical support and leadership in statistical programming across Biostatistics and other departments.
  • Develop custom SAS or other software code to create summary tables, data listings, graphs, and derived datasets per statistical analysis plans.
  • Lead the development of tools, macros, and process improvements for standardization and efficiency.

Compliance and Standards

  • Serve as a subject matter expert in CDISC and regulatory requirements, performing compliance reviews of SDTM, ADaM, and DEFINE.XML deliverables.
  • Enforce adherence to company, regulatory, and industry standards within and across projects.

Project Leadership

  • Oversee complex, global projects, mentoring team members and ensuring timelines are met.
  • Review CRFs, databases, and Statistical Analysis Plans (SAPs) to promote project standardization.
  • Act as a primary customer interface, presenting status updates and ensuring client satisfaction.

Mentorship and Training

  • Train and mentor Biometrics staff in advanced programming techniques, industry standards, and clinical trial processes.
  • Develop and deliver training programs to enhance team expertise.

Documentation and Audit Readiness

  • Maintain comprehensive project documentation, ensuring inspection readiness and quality control.
  • Participate in internal and external audits as needed.

Collaboration and Business Development

  • Support business development efforts through contributions to proposals, budgets, and sponsor presentations.
  • Collaborate with cross-functional teams to align statistical programming activities with project goals.

Qualifications

Education and Experience

  • Bachelor’s degree (scientific/statistical discipline preferred) or equivalent experience.
  • Extensive SAS programming experience, preferably in clinical trials, with demonstrated ability to lead complex projects.
  • Knowledge of CDISC standards and experience with regulatory submissions (preferred).

Skills and Competencies

  • Strong leadership, organizational, and time management skills.
  • Expertise in clinical trial processes and industry standards.
  • Excellent communication and interpersonal skills, capable of mentoring and influencing stakeholders.
  • Proficiency in English (written and verbal).

Why Syneos Health?

Professional Growth

  • Career advancement, therapeutic area training, and peer recognition programs.

Inclusive Environment

  • A Total Self culture that values diversity, authenticity, and belonging.

Industry Impact

  • Experience with 94% of FDA-approved drugs over the past five years.

Application Details

Ready to innovate and drive meaningful impact? Apply Now to join Syneos Health and shape the future of biopharmaceutical solutions. Not ready yet? Join our Talent Network for updates on new opportunities.

Be part of the change. Work here matters everywhere.