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Sr Principal Stat Programmer

0-2 years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Syneos Health Job Opportunity

Position: Senior Principal Statistical Programmer
Location: India-Asia Pacific - Home-Based
Job ID: 25001362
Updated: February 11, 2025


Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into outcomes, we address modern market challenges. Our approach centers around the patient and customer, continuously streamlining processes to simplify collaboration and foster innovation.

With 29,000 employees in over 110 countries, Syneos Health is committed to shaping the future of clinical development and biopharmaceutical services. We prioritize diversity and inclusion, empowering employees to bring their authentic selves to work.


Why Work Here

  • Career Development: We focus on career progression through development opportunities, technical and therapeutic area training, and peer recognition.

  • Total Self Culture: We create an inclusive, supportive environment where employees are encouraged to be their authentic selves.

  • Diversity and Inclusion: We foster a culture where diverse thoughts, backgrounds, and perspectives drive success.


Key Responsibilities:

  1. Programming Expertise:

    • Provide technical support and expertise across the Biostatistics function.

    • Develop custom programming code (SAS or other software) to generate statistical summaries, data listings, graphs, and derived datasets as per specifications.

    • Lead the development of process improvements, tools, and macros to enhance efficiency and standardization.

  2. Process Improvement & Analysis:

    • Analyze programming and data challenges, proposing innovative solutions.

    • Drive standardization of CRFs, databases, and statistical analysis plans.

    • Review and promote the standardization of key deliverables across projects.

  3. Team Mentoring & Development:

    • Mentor junior members of the Biometrics Department on new and traditional programming approaches.

    • Provide training and foster continuous learning.

  4. Compliance & Quality Control:

    • Ensure compliance with company, regulatory, and industry standards.

    • Develop and review specifications, ensuring inspection readiness for audits and regulatory reviews.

  5. Customer & Project Management:

    • Represent the department in client meetings, presenting updates and discussing project progress.

    • Provide project oversight and ensure timely delivery of statistical programming tasks.

  6. Industry Leadership:

    • Participate in industry standards organizations and contribute to presentations at conferences.

    • Lead or contribute to the development of Standard Operating Procedures (SOPs) and regulatory compliance efforts (e.g., CDISC, SDTM, ADaM).


Qualifications:

  • Education: Undergraduate degree, preferably in scientific or statistical discipline. Equivalent experience or technical expertise in programming is acceptable.

  • Experience:

    • Extensive programming experience in SAS (or other software), preferably in a clinical trial environment.

    • Knowledge and experience in CDISC standards for regulatory submissions.

    • Experience with regulatory submissions is preferred.

    • Proven experience in mentoring others and leading complex global projects.

  • Skills:

    • Strong communication, presentation, and interpersonal skills, with the ability to influence and persuade.

    • Ability to read, write, and understand English.


Additional Information:

  • Travel: Minimal travel may be required.

  • Compliance: Adheres to applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).

  • Business Development: Support business development through proposals, budget planning, and client meetings.


Why Syneos Health?

  • Impact: Work that directly impacts the delivery of therapies and improves patients’ lives.

  • Collaboration: Work with passionate problem solvers and innovators.

  • Diversity: A workplace that values diverse perspectives and fosters a sense of belonging.


How to Apply:

Visit the Syneos Health careers page to apply or join our Talent Network for future opportunities.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, sexual orientation, veteran status, disability, or any other legally protected status.

For inquiries regarding disability accommodations in the application process, contact: jobs@syneoshealth.com.