Senior Statistical Programmer (Remote) – SDTM/ADaM Expert

Datawise Inc; United States; Remote; USD 120,000 - 180,000; Part time

Job summary

Datawise Inc. is seeking a Contractor - Senior Statistical Programmer for a remote role. The successful candidate will develop, validate, and maintain clinical trial analyses, ensuring CDISC compliance and regulatory readiness for multiple indications.

You will create and validate SDTM and ADaM datasets, generate TLFs for CSRs and submissions, perform QC, and mentor junior programmers while collaborating with cross-functional study teams to ensure timely, high-quality deliverables.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
• Minimum 5 years of relevant biopharma/biotech/CRO experience.
• Experience in late-phase (phase III) trials is highly desirable.
• Proficiency in SAS programming.

Responsibilities

• Develop and validate SDTM and ADaM datasets per CDISC standards.
• Generate tables, listings, and figures (TLFs) for trials and regulatory submissions.
• Ensure accuracy, timeliness of analyses and deliverables.
• Perform QC checks on all programming outputs.
• Lead and mentor junior programming staff.
• Collaborate with cross-functional study teams.

Skills

SAS programming

CDISC standards

SDTM/ADaM development

Leadership & mentoring

Education

Bachelor’s or Master’s in Statistics/CS or related

Job description

Datawise Inc. is seeking a Contractor - Senior Statistical Programmer for a remote role. The successful candidate will develop, validate, and maintain clinical trial analyses, ensuring CDISC compliance and regulatory readiness for multiple indications.

You will create and validate SDTM and ADaM datasets, generate TLFs for CSRs and submissions, perform QC, and mentor junior programmers while collaborating with cross-functional study teams to ensure timely, high-quality deliverables.