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,