Job Description

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

• Bachelor’s degree + 5 years or Master’s + 3 years of statistical programming experience in pharma/biotech.
• Expertise in SAS programming within clinical trials.
• Strong working knowledge of CDISC standards (SDTM, ADaM).
• Experience with regulatory submissions (FDA/EMA/PMDA).
• Familiarity with statistical concepts, clinical development, and biometrics workflows.
• Knowledge of R or Python is a plus.
• Strong communication, organization, and problem-solving skills.
• Self-motivated and detail-oriented with the ability to manage multiple projects.

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