Lead Statistical Programmer — CDISC, TLFs & Submissions

Veriipro; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Veriipro is seeking an experienced Principal Statistical Programmer to lead statistical programming activities for clinical development programmes. The role requires strong expertise in SAS programming, CDISC standards, ADaM datasets, and TLF development, with a track record of supporting regulatory submissions.

You will provide technical leadership, mentor programmers, and collaborate with cross-functional teams including Statisticians, Medical Writing, and Regulatory Publishing to ensure

Qualifications

• Experience leading a team of statistical programmers.
• Strong SAS programming for ADaM, TLFs, and analyses.
• Knowledge of CDISC SDTM/ADaM and regulatory requirements.
• Experience supporting regulatory filings and submissions.
• Experience in Oncology, Immunology, Neuroscience or similar domains.

Responsibilities

• Lead statistical programming activities for assigned compounds, indications, or therapeutic areas.
• Mentor statistical programmers, analysts, and senior analysts.
• Plan resources, track deliverables, and ensure timely completion of programming activities.
• Develop and oversee SAS programs for ADaM dataset creation following CDISC standards.
• Develop and review SAS programs for Tables, Listings, and Figures (TLFs).
• Ensure consistency and quality of ADaM datasets across studies and analyses.
• Support regulatory submissions by preparing documentation such as reviewer guides.
• Develop standard SAS macros, programming standards, and SOPs.
• Ensure compliance with quality processes and clinical programming best practices.
• Collaborate with Statisticians, CDM, Medical Writing, Regulatory Publishing, and Clinical Operations teams.

Skills

Team leadership

SAS programming

ADaM datasets

TLFs

CDISC SDTM/ADaM

Regulatory submissions

Clinical trial data analysis

R programming

Cross-functional collaboration

Job description

Veriipro is seeking an experienced Principal Statistical Programmer to lead statistical programming activities for clinical development programmes. The role requires strong expertise in SAS programming, CDISC standards, ADaM datasets, and TLF development, with a track record of supporting regulatory submissions.

You will provide technical leadership, mentor programmers, and collaborate with cross-functional teams including Statisticians, Medical Writing, and Regulatory Publishing to ensure