Lead Statistical Programmer — SDTM/ADaM & CDISC Expert

Tech Observer; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Tech Observer, a global CRO, seeks an experienced Lead Statistical Programmer to lead programming across clinical studies, ensuring SDTM/ADaM datasets and TLFs meet regulatory standards.

The role requires mentoring junior programmers, developing reusable SAS macros, and collaborating with biostatistics, data management, and operations to deliver high-quality datasets and outputs for submissions.

Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or related field; Master’s preferred.
• 10+ years of relevant statistical programming experience in pharma/CRO/clinical research.
• Strong hands-on SAS programming with CDISC SDTM/ADaM expertise.
• Experience in clinical trial datasets, TLFs, and regulatory submissions.
• Experience mentoring junior programmers and leading projects.

Responsibilities

• Lead programming activities across clinical studies and projects.
• Develop, validate, and QC SAS/R programs for processing and reporting.
• Create SDTM/ADaM datasets and documentation with complex derivations.
• Program and QC Tables, Listings, and Figures (TLFs) per SAPs.
• Develop programming specifications for SDTM/ADaM; support regulatory submissions.

Skills

SAS programming

CDISC SDTM/ADaM

TLF development & QC

Regulatory submissions knowledge

Leadership / mentoring

Clinical study data analysis

Programming QC

SAS macros & automation

Cross-functional collaboration

Education

Bachelor's degree in Statistics/Biostatistics/Math/CS/Life Sciences

Master's degree preferred

Tools

SAS

R

Job description

Tech Observer, a global CRO, seeks an experienced Lead Statistical Programmer to lead programming across clinical studies, ensuring SDTM/ADaM datasets and TLFs meet regulatory standards.

The role requires mentoring junior programmers, developing reusable SAS macros, and collaborating with biostatistics, data management, and operations to deliver high-quality datasets and outputs for submissions.