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Senior Statistical Programmer – Adam, Tlfs

5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: Advanced degree (Master’s preferred) in Statistics, Computer Science, Biostatistics, or a related field 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: Senior Statistical Programmer – ADaM, TLFs

📍 Location: Hyderabad, India (Hybrid)
🆔 Job ID: 25101361
📅 Posted: August 28, 2025


🏢 About Syneos Health®

Syneos Health® is a fully integrated, biopharmaceutical solutions organization helping clients accelerate success. We align clinical development, medical affairs, and commercial insights to bring therapies to market faster and more effectively.

  • 🌍 29,000+ employees across 110 countries

  • 💊 Supported 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years

  • 🧪 Delivered 200+ studies across 73,000 sites and 675,000+ trial patients

🔗 Visit us at www.syneoshealth.com


🌟 Why Work at Syneos Health?

  • Career development and growth opportunities

  • Supportive and collaborative management

  • Extensive technical and therapeutic training

  • Recognition programs and total rewards benefits

  • Commitment to diversity, equity, and inclusion through our Total Self Culture


💼 Role Summary – P22 Level

As a Senior Statistical Programmer, you will design, code, test, and document statistical programs to support clinical trial analysis (ADaM datasets, Tables, Listings, and Figures). You’ll work with statisticians and project teams to ensure data accuracy, process efficiency, and compliance with regulatory standards.

This is a P22-level role, responsible for owning programming activities, mentoring junior staff, and enhancing process performance.


🧠 Key Responsibilities

  • Develop and maintain ADaM datasets, tables, listings, and figures (TLFs)

  • Ensure accuracy, integrity, and compliance of statistical programming deliverables

  • Support statistical analysis needs of statisticians, clients, and internal stakeholders

  • Source, organize, and interpret complex clinical datasets

  • Troubleshoot and resolve programming-related issues

  • Evaluate and improve programming processes, tools, and workflows

  • Direct or mentor junior-level programmers

  • Collaborate with cross-functional teams to deliver high-quality outputs

  • Stay current on statistical programming trends, tools, and standards


🎓 Qualifications

Education

  • Advanced degree (Master’s preferred) in Statistics, Computer Science, Biostatistics, or a related field

Experience

  • Minimum 5 years of statistical programming experience in clinical trials or pharmaceutical domains

  • Expertise in developing Safety & Efficacy datasets (ADaM)

  • Strong experience creating and validating TLFs


💻 Technical Skills

  • Expert-level proficiency in SAS (Base, Macros, SQL)

  • Experience with R or Python is a plus

  • Strong understanding of CDISC standards (ADaM, SDTM)

  • Familiarity with data visualization tools and clinical trial data models

  • Solid grasp of statistical methodologies


🏅 Certifications (Preferred but not mandatory)

  • SAS Certified Advanced Programmer for SAS 9

  • Certifications in data analysis or statistical programming


🧩 Core Skills & Competencies

  • Strong analytical and problem-solving skills

  • High attention to detail and quality-focused mindset

  • Ability to manage multiple priorities and projects

  • Excellent communication and collaboration skills

  • Adaptability to changing project scopes and business needs

  • Ability to work independently and mentor others


📌 Core Focus Areas

  • Development of ADaM datasets, TLFs, and submission-ready outputs

  • Statistical programming support for clinical trial data analysis

  • Process improvement and programming standardization

  • Leading or supporting cross-functional projects

  • Mentoring and guiding junior programmers


⚠️ Additional Information

  • This job description is not exhaustive and responsibilities may evolve

  • Syneos Health is committed to equal opportunity, disability inclusion, and workplace accommodations

  • This is not a contractual offer of employment


📥 How to Apply

🔗 Apply for this job
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