Lead Statistical Programmer Job at Confidential, Malvern, PA

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  • Confidential
  • Malvern, PA

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.

Job Tags

Permanent employment, Contract work, Local area,

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