Location: India (Remote)
Company: Syneos Health
Job ID: 25105430
Experience Required: 8+ years (Not suitable for freshers)
About the Company
Syneos Health is a globally established, fully integrated biopharmaceutical solutions organization that accelerates clinical development and commercialization outcomes. With a strong presence across global markets, the organization collaborates with leading pharmaceutical and biotech companies to deliver high-impact healthcare solutions.
Job Overview
The Principal Statistical Programmer is a senior-level, client-facing role responsible for leading statistical programming activities across clinical trials. This position requires deep expertise in clinical data standards, advanced programming, and leadership in delivering high-quality statistical outputs aligned with regulatory requirements.
This role is ideal for experienced professionals who can independently manage complex datasets, lead programming teams, and drive innovation in statistical programming processes.
Key Responsibilities
Lead the development, validation, and maintenance of statistical programming standards and best practices
Provide technical leadership in creating analysis datasets, tables, listings, and figures (TLFs)
Collaborate with statisticians, sponsors, and cross-functional teams to translate study requirements into programming deliverables
Ensure accuracy, consistency, and regulatory compliance of statistical outputs
Design and implement efficient, scalable programming solutions for clinical trial data
Perform troubleshooting, debugging, and resolution of complex programming challenges
Conduct code reviews and ensure adherence to quality standards and SOPs
Mentor and guide junior programmers, supporting team capability development
Act as a primary point of contact for clients, managing timelines, expectations, and deliverables
Continuously improve programming workflows, tools, and automation strategies
Required Qualifications
Advanced degree in Statistics, Computer Science, or related discipline
Minimum 8+ years of experience in clinical statistical programming within CRO, pharma, or biotech industry
Strong hands-on expertise in ADaM and TLF development (mandatory)
Working knowledge of SDTM standards (preferred)
Proven experience in study lead roles with client-facing responsibilities
Strong understanding of clinical trial data, statistical methodologies, and regulatory requirements
Excellent analytical thinking and problem-solving capabilities
Strong communication and stakeholder management skills
Technical Skills
Proficiency in SAS (mandatory); experience with R or Python is an added advantage
Expertise in clinical data standards such as CDISC (ADaM, SDTM)
Experience in generating regulatory-compliant outputs for submissions (FDA, EMA)
Ability to manage large-scale datasets and complex programming workflows
Preferred Certifications
SAS Certified Advanced Programmer for SAS 9 or equivalent
Role Impact and Career Scope
This is a high-impact leadership role within the Statistical Programming function, contributing directly to global clinical trial delivery. Professionals in this role are recognized as subject matter experts and play a critical role in shaping programming strategies, improving operational efficiency, and influencing study outcomes.
Important Note for Applicants
This is a senior-level opportunity requiring extensive hands-on experience in statistical programming and clinical trials. Freshers or entry-level candidates are advised to explore roles such as Statistical Programmer I or Clinical Data Analyst to build foundational experience before progressing to principal-level roles.
Why This Role Stands Out
Remote flexibility with global project exposure
Opportunity to lead high-value clinical development programs
Direct client interaction and strategic decision-making involvement
Strong career progression within a global CRO environment
How to Apply
Apply through the official careers page of Syneos Health or explore verified global opportunities on ThePharmaDaily.com
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