Tech Observer
Principal Statistical Programmer-FSP
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Statistician – SAS Programmer
About Tech Observer
Tech Observer is a Global Clinical Research Organization (CRO) and FSP provider, offering support to the Pharmaceuticals & Life Sciences Industry since 2005. Our offices are based in New Jersey (HQ), India, Denmark, UK & Singapore, with access to Australia, China, Malaysia, South Korea, Taiwan, Thailand, Vietnam, and other countries through local partners.
Job Title & Overview
Statistician – SAS Programmer
This role involves ensuring data integrity, compliance, and excellence in clinical research programming. You will develop, validate, and refine SAS and R programs, Mockshells, programming logs, SDTM (Study Data Tabulation Model) and ADaM (Analytic Data Model), ensuring adherence to ICH GCP, FDA/COMP, and ICH E6/R2, working under the supervision of a Statistical Director/Sr. Educational and/or Data Manager.
Key Responsibilities
The Statistician–SAS Programmer will provide expert support in clinical data programming, including:
- Compliance & Development
- Execute all programming activities as per Tech Observer/Client SOPs, maintaining Quality Management System (QMS) and Good Clinical Practice (GCP) standards.
- Ensure adherence to programming guidelines with full regulatory compliance.
- Review and validate study documentation (CRF, Metadata, Protocols, SAP, Mockshells).
- Develop table/analytic status dты and validate SDTM (SDt tableaux) and ADaM programs.
- Perform QC review of initially programmed tables/ADDa and supporting documentation.
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Statistical and Programming Expertise
- Write and debug proprietary SAS/R programs for:
- SDTM dataset development & QC
- ADaM dataset generation & verification
- Statistical report tables (Tables, Listings, and Figures)
- Randomization schedules
- Develop and QC SDTM/ADaM metadata, e-submission packages, specifications, and DS support.
- Collaborate with programmers and supervisors on development, re-programming, and remediation.
- Write and debug proprietary SAS/R programs for:
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Consulting & Training
- Provide training and advice for SAS programmers in SDTM/ADaM principles and regulatory expectations.
- Mentor junior SAS programmers.
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Process Improvement & Quality Assurance
- Promote best practices, document initiatives, and enforce standard operating procedures (SOP).
- Drive system and process improvements to enhance efficiency and data integrity.
- Prepare SOPs for regulatory documentation.
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- General Duties
- Execute tasks as assigned, including programming activities and problem-solving needs, with minimal supervision.
- Maintain 100% compliance to ensure quality and precision.
- Adapt growth mindset to improve coding and regulatory domain knowledge.
Candidate Profile
Required
- Strong bio-statistcadSAS skills, including proficiency in SDTM, ADaM, and Mockshells/Log programming.
- Familiarity with ICH GDPM, PRO2C, GMP systems for statistical objectives.
- Exceptional cadrical integrity, judgment, analysis, and teamwork skills.
- Ability to cope with multiple tasks under deadlines, prioritising efficiently.
- Programming data intensive (Excel), data analytics, and lor statistics tools.
- Committed to continuously upskilling in clinical, statistical, and programming domains.
Preferred (η but not limited to)
- Familiarity with SAS-based data retrieval tools, regression analysis, bio-statistics, and team coordination for project workflows.
How to Apply
For more information about Tech Observer, visit our website.
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