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Clinical-Research-Associate-Ii-Home-Based-Delhi-Cvd-Experience-Preferred

0-2 years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Senior Principal Statistical Programmer

Company: Syneos Health
Updated: 06-Nov-2025
Location: Remote – India
Job ID: 25102468


About Syneos Health

Syneos Health is a global biopharmaceutical solutions organization that integrates clinical, medical, and commercial services.

  • 29,000 employees, 110 countries

  • Worked with 94% of FDA-approved drugs in last 5 years

  • Worked with 95% of EMA-authorized products

  • Supported 200+ studies, 73,000 sites, 675,000+ patients

WORK HERE MATTERS EVERYWHERE


Position Overview

The Senior Principal Statistical Programmer provides high-level statistical programming expertise, project leadership, and submission support across clinical studies and programs.
This role requires deep ADaM + CDISC mastery, proven study leadership, and the ability to independently manage client communication.


Experience Requirement

  • 10+ years overall Statistical Programming experience

  • Strong ADaM & CDISC expertise

  • Proven track record of leading multiple clinical studies


Technical Skills – Must Have

ADaM Expertise

  • ADaM specification development

  • ADaM dataset programming & review

  • Handling complex ADaM and TFL programming tasks

CDISC Standards

  • Deep understanding of CDISC standards (SDTM, ADaM)

  • Experience applying CDISC across Phase I–III trials

Client Interaction

  • Ability to communicate directly with client technical leads

  • Can independently manage projects without US-based support


Study Management Requirements

  • Must have independently led at least 4–5 clinical studies

  • Ability to lead multiple studies simultaneously (global/large-scale preferred)

  • Capability to manage end-to-end study delivery with minimal oversight

  • Exposure to portfolio-level oversight, particularly ISS (Integrated Summaries)


Good-to-Have Skills

  • Prior ISS (Integrated Summary of Safety/Efficacy) experience

  • Experience with diverse study designs

  • Understanding of integration workflows


Key Responsibilities

1. Statistical Programming Leadership

  • Provide programming consultancy and technical leadership

  • Guide ADaM, SDTM, and TFL programming across studies

  • Develop overall programming strategy for projects/submissions


2. Project & Submission Management

  • Support analysis, reporting, and regulatory submission preparation

  • Lead cross-functional teams to ensure study deliverables

  • Identify trends across projects and implement improvements


3. Technical Excellence

  • Serve as a subject matter expert (SME) for ADaM, CDISC, and industry standards

  • Drive innovation and improve biostatistics tools and processes

  • Ensure programming complies with regulatory requirements


4. Collaboration & Client Engagement

  • Influence internal teams and clients to achieve quality outcomes

  • Provide hands-on guidance during complex programming tasks

  • Lead interactions with sponsors on technical matters


Role Summary

This role combines:

  • High technical expertise (CDISC, ADaM, regulatory requirements)

  • Strategic leadership across studies or programs

  • Hands-on programming when required

  • Mentorship & SME responsibilities to support the Biostatistics department

A Senior Principal Statistical Programmer acts with full independence, drives end-to-end delivery, and significantly shapes programming strategy and quality across the portfolio.