Location: India (Remote)
Company: Syneos Health
Job ID: 25107315
Experience Required: 8+ years (Not suitable for freshers)
About the Company
Syneos Health is a globally recognized biopharmaceutical solutions organization delivering end-to-end clinical development and commercialization services. The organization partners with leading pharmaceutical and biotech innovators to accelerate drug development and improve patient outcomes across global markets.
Job Overview
The Senior / Principal Statistical Programmer is a strategic and technical leadership role within clinical development. This position is responsible for advanced statistical programming, regulatory submission support, and ensuring high-quality data outputs aligned with global clinical trial standards.
This is a remote opportunity for experienced professionals with deep expertise in SAS programming, CDISC standards, and regulatory submissions.
Key Responsibilities
Develop and validate SAS programs to generate statistical outputs including Tables, Listings, and Figures (TLFs) as per Statistical Analysis Plans (SAPs)
Create and manage analysis datasets including ADaM and SDTM in compliance with CDISC standards
Perform validation programming and resolve discrepancies in collaboration with biostatisticians and cross-functional teams
Lead programming activities across multiple clinical projects, ensuring timely and high-quality deliverables
Review and interpret key study documents such as SAPs, annotated CRFs, and mock shells to optimize programming efficiency
Develop programming specifications for complex datasets and outputs with minimal rework
Act as a subject matter expert for CDISC standards, including SDTM, ADaM, and Define.xml
Support regulatory submissions by preparing submission packages such as ADRG and Define.xml
Provide technical leadership, mentorship, and training to junior programmers
Participate in sponsor meetings, audits, and bid defense presentations as statistical programming lead
Ensure compliance with ICH guidelines, GCP standards, and internal SOPs
Contribute to the development of standard macros, tools, and automation frameworks to improve efficiency
Required Qualifications
Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related discipline (advanced degree preferred)
Minimum 8+ years of experience in Clinical SAS Programming within CRO, Pharma, or Biotech industry
Strong expertise in:
ADaM and TLF programming (safety and efficacy outputs)
SDTM dataset creation and validation
Regulatory submission deliverables including ADRG and Define.xml
Hands-on experience with CDISC standards and electronic submission requirements
Strong analytical thinking, problem-solving, and stakeholder communication skills
Ability to manage multiple projects and deliver under tight timelines
Why This Role Stands Out
Fully remote global opportunity with a leading CRO
High-impact role contributing to regulatory submissions and drug approvals
Exposure to global clinical trials and regulatory frameworks
Leadership and mentorship opportunities within a highly skilled biometrics team
Important Note for Applicants
This is a senior-level role requiring extensive experience in statistical programming and clinical trials. Freshers or early-career professionals should consider entry-level roles such as SAS Programmer, Clinical Data Analyst, or Biostatistics Associate before progressing to this level.
How to Apply
Apply directly through the official careers page or explore verified global pharma opportunities on ThePharmaDaily.com
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