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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

Principal Statistical Programmer

Location: Syneos Health, Global


About Syneos Health

Syneos Health is a premier biopharmaceutical solutions company focused on accelerating customer success. With a commitment to modern market realities, we translate clinical, medical, and commercial insights into impactful outcomes. Our approach places the customer and patient at the center of everything we do, ensuring the development and delivery of life-changing therapies. With a global workforce of over 29,000 employees, we operate across 110 countries.
"Work Here Matters Everywhere."


Why Syneos Health?

At Syneos Health, we nurture talent and offer opportunities for career development, training, and advancement. We believe in building a diverse and inclusive work environment where you can be your authentic self. Our culture—Total Self—unites us and ensures that every individual feels they belong.


Key Responsibilities

  • Programming & Data Management:

    • Use SAS or other relevant software to generate custom programming code for summary tables, data listings, graphs, and derived datasets as per the statistical analysis plan.

    • Ensure that outputs meet quality standards and project requirements, performing validation programming as necessary.

    • Maintain well-organized project documentation, ensuring inspection readiness.

  • Collaboration & Leadership:

    • Act as the Lead Statistical Programmer, managing programming tasks across multiple projects.

    • Direct the programming activities of other programming personnel and monitor the timely delivery of project outputs.

    • Participate in internal and sponsor meetings, ensuring alignment with project requirements and timelines.

  • Compliance & Standards:

    • Apply CDISC Standards for regulatory compliance, ensuring datasets meet SDTM, ADaM, and DEFINE.XML specifications.

    • Guide and mentor teams in CDISC Standards, regulatory requirements, and clinical trial processes.

    • Perform compliance reviews for deliverables and actively engage with industry standards organizations to stay updated.

  • Project Delivery & Risk Management:

    • Manage scheduling and deadlines across multiple projects, ensuring on-time delivery of programming tasks.

    • Provide risk mitigation plans for programming deliverables and communicate status updates to management.


Qualifications

Education & Experience:

  • Undergraduate degree (preferably in a scientific/statistical field) or equivalent combination of education and programming experience.

  • Extensive SAS programming experience in a clinical trial environment, leading global or complex projects.

  • Familiarity with CDISC Standards and prior experience with regulatory agency submissions is preferred.

  • Experience mentoring and training junior programmers.

Skills & Competencies:

  • Strong organizational and leadership skills.

  • Excellent communication skills, both written and verbal, with fluency in English.

  • In-depth knowledge of clinical drug development and industry standards.


Why Work with Us?

  • Career Development: Opportunities for growth, progression, and peer recognition.

  • Inclusive Culture: Join a team where your diverse perspectives are valued, and everyone feels a sense of belonging.

  • Impactful Work: Contribute to the development of therapies that make a real difference in patients’ lives.


Additional Information:

Syneos Health embraces diversity and inclusion. If your experience doesn’t align perfectly with the job description, we encourage you to apply anyway. We also value transferable skills from other roles and encourage you to join our Talent Network for additional career opportunities.
Minimal travel may be required.


Apply Today to join a company that values your contributions and supports your career growth!