Job Description

Part-Time Biostatistician / Statistical Programmer (CDISC SDTM/ADaM)

ClinCapture — San Francisco, CA (Hybrid, 1 Day/Week Onsite)

About ClinCapture

ClinCapture, Inc. is a digital health software company with offices in San Francisco, CA and Las Vegas, NV.

ClinCapture is a leading provider of Electronic Data Capture (EDC) software, helping life sciences companies run clinical trials efficiently and compliantly. As we expand into professional services, we are seeking a part-time Biostatistician / Statistical Programmer to support CDISC dataset generation and regulatory submission deliverables.

At ClinCapture, our mission is to build "software that saves lives." Our technology lowers the cost of clinical research by accelerating clinical study workflows, while providing a platform that protects patient privacy. ClinCapture advances the evaluation and development of new medicines, medical devices, and diagnostics which demonstrate promise for a wide range of medical conditions.

Position Summary

We are looking for a skilled Biostatistician / Statistical Programmer to join our team on a part-time basis (10–20 hours per week). This role will focus on building SDTM and ADaM datasets, preparing submission-ready packages, and generating outputs for clinical study reports and regulatory filings.

The initial role is part-time with potential for full-time work as our services grow.

This is a hybrid position based in San Francisco. The candidate must be available to work onsite 1 day per week for collaboration with the internal team.

Responsibilities

• Build and validate CDISC SDTM and ADaM datasets for FDA/EMA regulatory submissions.
• Generate statistical outputs (Tables, Listings, Figures) for CSRs, interim analyses, and regulatory reporting.
• Prepare submission documentation, specifications, mapping documents, and define.xml.
• Collaborate with clinical data management and project teams to ensure data quality, compliance, and readiness.
• Perform statistical programming in SAS and/or R to support study deliverables.
• Ensure timely, high-quality deliverables that meet regulatory and sponsor expectations.

Qualifications

• 3+ years of experience in clinical trials statistical programming.
• Strong expertise with CDISC SDTM and ADaM standards.
• Proficient in SAS (BASE, MACRO, STAT); R experience is a plus.
• Familiarity with FDA/EMA submission requirements and submission-ready datasets.
• Experience with clinical data, data management, and clinical coding is a plus.
• Excellent attention to detail and strong documentation skills.
• Strong communication and ability to work independently.
• Must be located in the San Francisco Bay Area and able to work onsite one day per week.

Compensation

• $90–$100/hour DOE
• Part-time: 10–20 hours per week

To Apply

Please submit your resume and a brief cover letter describing your experience with SDTM/ADaM and clinical trial submissions.

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