Lead Statistical Programmer

Lead Statistical Programmer (Onsite – 5 Days / Week)

Location : Malvern PA , Local candidates only – onsite 5 days / week

Duration : Perm / Contract to hire

Industry : Ophthalmology | Gene Therapy | Biologics | Rare Disease

Looking for Local candidates only

About the Company

A fast-growing ophthalmology biotech advancing innovative gene and cell therapies and biologics for rare and underserved ocular disorders. The team is expanding rapidly and building a strong Biometrics function.

Position Overview

We are seeking a Lead Statistical Programmer with strong regulatory submissions experience (FDA / EMA / PMDA). You will lead programming activities across multiple clinical studies, ensuring high-quality, compliant deliverables using SAS, CDISC standards, and TLF development. This role partners closely with Biostatistics, Data Management, and CRO teams.

Key Responsibilities

• Lead programming activities for SDTM , ADaM , and TLFs across clinical studies.
• Develop, validate, and maintain analysis datasets following CDISC standards.
• Support regulatory submissions including eCRT, Define.xml, and integrated data packages.
• Write and review programming specifications , SAP mock shells, and documentation.
• Ensure high-quality, reproducible results using SAS (Base, Macro, Stat) and other tools.
• Collaborate with cross-functional teams and CROs to ensure clean, timely deliverables.
• Provide statistical programming support for study design, randomization, data review, and reporting.
• Participate in department process improvements, SOP updates, and project planning.

Qualifications