Senior Statistical Programmer/Analyst Consultant – TA, Gene Therapy

🔥 2 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

😶‍🌫️ Therapist

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting • Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs) • Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications • Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses • Support interim and final analyses, database lock activities, and Clinical Study Report preparation • Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements • Perform independent validation and quality control of datasets, TLFs, and other programming outputs • Support regulatory submissions and address programming-related questions from internal and external stakeholders • Manage study-level programming timelines, deliverables, and quality expectations • Identify and resolve complex programming issues and proactively communicate risks • Provide technical guidance and mentorship to other Statistical Programmers • Participate in client-facing meetings and collaborate with cross-functional project teams

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field • Significant experience in clinical trial statistical programming within a pharmaceutical, biotechnology, or CRO environment • Hands-on experience supporting Gene Therapy clinical trials is required • Strong proficiency in SAS programming • Strong knowledge of CDISC standards, including SDTM and ADaM • Experience developing and validating clinical trial TLFs • Ability to independently lead study-level programming activities • Understanding of clinical trial processes, statistical analysis, and regulatory reporting • Excellent analytical, communication, and problem-solving skills

🏖️ Benefits

• Professional development and training • Supportive culture • Close management and training • Continuous training • Equal opportunity and diversity/inclusivity commitment