Contractor - Senior statistical programmer - Remote

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

This is a Contractor - Senior statistical programmer - Remote position in a CRO. This position will play a key role in the development, validation, and maintenance of clinical trial data analyses. This position ensures compliance with CDISC standards, adherence to regulatory requirements, and efficient execution of statistical programming deliverables. The role involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications.

Key Responsibilities

Develop and validate SDTM and ADaM datasets in accordance with CDISC standards.

Generate high-quality tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.

Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables.

Perform rigorous quality control (QC) checks on all programming outputs.

Troubleshoot and resolve data and programming issues efficiently.

Collaborate with cross-functional study teams to support accurate and consistent data reporting.

Promote programming best practices by demonstrating strong technical expertise in statistical programming environments and tools.

Lead, mentor, and provide guidance to junior programming staff, fostering technical and professional development.

Ensure full compliance with regulatory submission requirements and CDISC standards (SDTM, ADaM).

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.
• Experience in late-phase (phase III) trials is highly desirable.
• Proficiency in SAS programming.
• Hands-on experience with raw datasets, SDTM, and ADaM dataset development.
• Strong analytical, problem-solving, and communication skills (both verbal and written).
• Ability to work effectively in a cross-functional environment, proactively influencing teams with innovative clinical development strategies.