Statistical Programmer
Skills & Expertise.
Build a high-performing biometrics team with dedicated offshore Statistical Programmers. They bring essential experience in developing SDTM and ADaM datasets, and programming Tables, Listings, and Figures (TLFs).
From maintaining CDISC standards to preparing global regulatory submissions, our professionals integrate seamlessly into your pharmaceutical company, biotech, or CRO operations.
Trusted by Growing Businesses Worldwide
Foundational Requirements
Essential Statistical Programmer Skills
A highly effective Statistical Programmer forms the backbone of a successful clinical data strategy. They ensure data integrity, perform meticulous validation, and drive reliable analytical outputs for regulatory submissions.
Education & Training
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline is preferred.
- Strong written and verbal English communication.
- Professional documentation and analytical communication skills.
- Commitment to ongoing learning in CDISC standards, ICH-GCP, and statistical programming.
Ideal Experience
- 2 to 5 years of statistical programming experience within a pharmaceutical company, biotechnology company, or CRO.
- Experience developing SDTM and ADaM datasets and programming Tables, Listings, and Figures (TLFs).
- Familiarity with SAPs, Define-XML, Pinnacle 21, and global regulatory submissions.
- Experience supporting Phase I-IV regional or global clinical trials.
Core Technical Skills
- Proficiency in SAS programming, SDTM and ADaM development, and statistical output generation.
- Strong knowledge of CDISC standards, SAPs, Define-XML, and regulatory submission requirements.
- Ability to develop submission-ready datasets, TLFs, and validated programming deliverables.
- Effective collaboration with Biostatistics, Clinical Data Management, Regulatory Affairs, Medical Writing, and Clinical Operations teams.
Software Proficiency
Key Tools & Platforms
Statistical Programming
Expertise in SAS, SAS Studio, and R for complex data manipulation and statistical output generation.
CDISC Validation
Hands-on experience navigating regulatory compliance using tools such as Pinnacle 21.
Version Control & Project Management
Equipped to track code and manage deliverables using Git and JIRA.
Clinical Data Sources
Proficient in sourcing and integrating data from EDC systems like Medidata Rave and Oracle Clinical One.
Productivity Suites
Seamlessly coordinates clinical reporting using Microsoft Excel, Microsoft Word, and Microsoft Outlook.
Results that Matter
Performance Metrics & Expectations
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Business Outcome
Submission-ready statistical outputs that effectively support clinical analysis and accelerate regulatory approval.
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Operational KPIs
Evaluated on programming accuracy, SDTM/ADaM validation, TLF delivery timelines, quality control findings, and overall submission readiness.
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Operational Excellence
Delivers validated datasets, fully compliant programming, efficient delivery, and highly reliable regulatory support throughout the trial lifecycle.
Transparent Pricing
All-inclusive rates. Dedicated biometrics support without hiring complexity.
One predictable monthly rate covers compensation, payroll, HR, equipment, account management, and operational support infrastructure. No recruitment fees. No hidden setup costs.
