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Principal Stat Programmer (Adam + Tfl)

2+ years
Not Disclosed
10 April 30, 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

Job Title: Principal Statistical Programmer (ADAM + TFL)

Company: Syneos Health
Job ID: 25002899
Updated On: April 22, 2025
Location: India-Asia Pacific – IND-Home-Based

About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By blending clinical, medical affairs, and commercial insights, Syneos Health delivers impactful outcomes to meet evolving market demands. With a team of 29,000 professionals across 110 countries, Syneos Health embodies the belief that "Work Here Matters Everywhere."

Why Join Us:

  • Career development and progression opportunities

  • Supportive and engaged line management

  • Comprehensive training in technical and therapeutic areas

  • Recognition and rewards programs

  • Commitment to diversity and inclusion through our Total Self culture

Job Responsibilities:

  • Develops custom programming code using SAS or other software to create summary tables, data listings, graphs, and derived datasets per the statistical analysis plan.

  • Ensures outputs meet quality standards and project requirements.

  • Performs validation programming and resolves discrepancies in collaboration with cross-functional teams.

  • Maintains up-to-date and organized project documentation for inspection readiness.

  • Manages time effectively across concurrent projects and adjusts workload as priorities shift.

  • Develops comprehensive specifications for datasets and outputs; anticipates potential programming issues.

  • Leads internal project meetings, ensures timely distribution of minutes, and follows through on action items.

  • Serves as the lead statistical programmer, overseeing and guiding other programming personnel.

  • Reviews project documentation including SAPs, mock shells, annotated CRFs, and programming specifications.

  • Represents programming in sponsor meetings and bid defenses, as needed.

  • Mentors junior programming staff and contributes to internal training initiatives.

  • Maintains expertise in clinical drug development and regulatory submission requirements.

  • Contributes to the creation of SOPs and programming tools to enhance standardization and efficiency.

  • Acts as CDISC subject matter expert, offering guidance on compliance and participating in industry standards groups.

  • Ensures regulatory deliverables like SDTM, ADaM datasets, and DEFINE.XML meet compliance requirements.

  • Handles data transfers and completes other work-related duties as assigned.

  • Minimal travel may be required.

Qualifications:

  • Bachelor’s degree in a scientific or statistical discipline (or equivalent education/experience).

  • Extensive SAS programming experience in clinical trials, with a proven track record in leading global projects.

  • In-depth knowledge of CDISC standards and regulatory submission processes.

  • Prior experience in mentoring and training teams on CDISC and clinical trial processes.

  • Excellent verbal and written communication skills.

  • Proficiency in English is required.

About Syneos Health (Additional Context):

  • 94% involvement in FDA-approved novel drugs over the last 5 years

  • Participation in over 200 studies across 73,000 sites and 675,000+ trial patients

  • Culture that values innovation, inclusivity, and impact in a dynamic environment

Note:
This job description is not exhaustive. Responsibilities and qualifications may be modified based on business needs. All applications will be considered based on experience, education, and overall fit to the role, as defined by Syneos Health standards and relevant employment legislation.