Confidential · 1 month ago
Lead Statistical Programmer
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
3+ years expConfidential company is a fast-growing ophthalmology biotech advancing innovative gene and cell therapies and biologics for rare and underserved ocular disorders. They are seeking a Lead Statistical Programmer with strong regulatory submissions experience to lead programming activities across multiple clinical studies, ensuring high-quality, compliant deliverables.
Staffing & Recruiting
Hiring Manager
Abid Kahn (MAK)
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
Qualification
Required
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
Strong communication, organization, and problem-solving skills
Self-motivated and detail-oriented with the ability to manage multiple projects
Preferred
Knowledge of R or Python is a plus
Company
Confidential
Centralizing All Types Of Next Opportunities For You In One Place.
Vancouver, US
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase