Statistical Programming Consultant

Confidential; Malvern (Chester County); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading biotechnology company in Malvern, PA is seeking a Principal Statistical Programmer. This role involves working closely with biostatistics teams to deliver high-quality programming support for clinical trials. The ideal candidate will have over 5 years of SAS programming experience and strong knowledge of CDISC standards. This position is office-based for 4 days a week and offers a competitive contract for 6+ months.

Qualifications

• 5+ years of SAS programming experience in a clinical trial environment.
• Strong working knowledge of CDISC standards.
• Experience leading programming for multiple studies preferred.

Responsibilities

• Develop and validate SDTM and ADaM datasets in compliance with CDISC standards.
• Create and review tables, listings, and figures (TLFs) for clinical trial reporting.
• Collaborate with CROs to ensure timely and accurate data delivery.

Skills

SAS programming

CDISC standards knowledge

Statistical analysis

Problem-solving

Communication

Organization

Education

BS/MS in Statistics, Computer Science, Mathematics, or Life Sciences

Tools

SAS (Base, Stat, Macro, Graph)

R

Python

Job description

Overview

Statistical Programming Consultant (Principal Statistical Programmer)

Office-based, 4 days/week – Malvern, PA

6+ Month Contract | 40 hrs/week

Client Overview: Our client is a rapidly growing ophthalmology biotechnology company advancing a pipeline of innovative therapies to address rare and underserved ocular disorders. With a focus on gene and cell therapies, biologics, and breakthrough treatments, they are committed to transforming global healthcare.

The Role

We are seeking an experienced Principal Statistical Programmer to join the client team. This consultant will work closely with the Director of Biostatistics, internal teams, and CROs to deliver high-quality statistical programming support for clinical trials, regulatory submissions, and cross-study integration.

Key Responsibilities

• Develop and validate SDTM and ADaM datasets in compliance with CDISC standards.
• Create and review tables, listings, and figures (TLFs) for clinical trial reporting.
• Write programming specifications and ensure accurate, reproducible analyses.
• Support statistical analysis plans, including mock-ups of displays and methodology descriptions.
• Collaborate with CROs to ensure timely, secure, and accurate data delivery.
• Assist in preparation of submission documents and electronic case report forms (eCRFs).
• Proactively identify risks, propose solutions, and support compliance with regulatory requirements.
• Contribute to SOP development, departmental training, and cross-functional meetings.

Qualifications

• BS/MS in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 5+ years of SAS programming experience in a clinical trial environment (Pharma/Biotech required).
• Strong working knowledge of CDISC (SDTM & ADaM) standards and regulatory submission processes.
• Proficiency in SAS (Base, Stat, Macro, Graph); knowledge of R and/or Python a plus.
• Solid understanding of statistical concepts and clinical trial principles.
• Experience leading programming for multiple studies or submissions preferred.
• Excellent communication, organization, and problem-solving skills.