Remote Senior Statistical Programmer: SDTM/ADaM (Contractor)

Datawise Inc; United States; Remote; USD 96,000 - 165,000; Full time

Job summary

Datawise Inc. is seeking a Senior Statistical Programmer for a remote contractor role within a CRO environment. You will develop and validate SDTM and ADaM datasets according to CDISC standards and generate TLFs to support regulatory submissions.

You will lead, mentor, and collaborate with cross-functional study teams to ensure timely, compliant analyses and deliverables across multiple indications.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
• Minimum 5 years of relevant experience in the biopharmaceutical, biotechnology, or CRO industry.
• Proficiency in SAS programming.
• Hands-on experience with raw datasets, SDTM, and ADaM dataset development.

Responsibilities

• Develop and validate SDTM and ADaM datasets in accordance with CDISC standards.
• Generate high-quality TLFs for clinical study reports and regulatory submissions.
• Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables.
• Perform rigorous QC checks on all programming outputs.
• Troubleshoot and resolve data and programming issues efficiently.
• Collaborate with cross-functional study teams to support accurate data reporting.
• Promote programming best practices and mentor junior staff while ensuring CDISC compliance.

Skills

SAS programming

Analytical thinking

Problem-solving

Communication skills

Cross-functional collaboration

Mentoring

Education

Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field

Job description

Datawise Inc. is seeking a Senior Statistical Programmer for a remote contractor role within a CRO environment. You will develop and validate SDTM and ADaM datasets according to CDISC standards and generate TLFs to support regulatory submissions.

You will lead, mentor, and collaborate with cross-functional study teams to ensure timely, compliant analyses and deliverables across multiple indications.