Senior Statistical Programmer/Analyst, Oncology

🔥 1 minute ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🖥 Software Engineer

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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 oncology clinical studies from study start-up through database lock, analysis, and reporting • Develop, review, and maintain SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs) • Lead programming activities for interim and final analyses, including complex efficacy and safety analyses • Work with Biostatisticians on statistical analysis plans, programming specifications, and study requirements • Develop and review programming specifications consistent with study protocols, SAPs, and statistical methodology • Support creation and validation of CDISC-compliant SDTM and ADaM datasets • Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables • Perform independent programming validation and quality control of statistical outputs and datasets • Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams • Identify programming issues and communicate risks, timelines, and solutions to project stakeholders • Coordinate programming activities across studies and ensure timely, high-quality deliverables • Provide technical guidance and mentorship to Statistical Programmers and other programming team members • Participate in client/project meetings and communicate technical information to technical and non-technical stakeholders

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field • Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment • Significant experience working on oncology clinical trials • Experience supporting regulatory submissions • Strong proficiency in SAS programming, including Base SAS and relevant SAS procedures used for clinical trial reporting • Strong knowledge of CDISC standards, particularly SDTM and ADaM • Experience developing and validating TLFs for clinical trials • Experience working with complex clinical trial data and supporting statistical analyses • Ability to independently manage programming deliverables and lead study-level programming activities • Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports • Excellent communication, organizational, problem-solving, and collaboration skills • Basic or working knowledge of R programming is preferred

🏖️ Benefits

• Security and additional career opportunities from working for a global CRO • Professional development • Supportive culture • Continuous training • Close management and training • Equal opportunity employer with a focus on diversity and inclusivity