Contractor - Senior statistical programmer - Remote

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

This is a Contractor - Senior statistical programmer - Remote position in a pharmaceutical company. 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.