ClinChoice

Director

• Lead and oversee statistical programming activities to support clinical trial projects
• Manage programmers and CROs and provide statistical programming oversight to vendors
• Review and validate datasets and TFLs programmed by vendors
• Support building programming processes for clinical studies and regulatory submissions
• Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver timely, high-quality data deliverables
• Develop and implement data review/reporting tools and other statistical applications as appropriate
• Review study documents (SAP, DMP, CRF, annotated CRF, TFL specifications) and provide expert feedback
• Build, mentor and manage a team of programmers to support clinical trials and pipelines
• Generate ad hoc analyses on an ongoing basis

Associate Director, Programming

Software Engineer

• Support Programming deliveries of a clinical study or project
• Implement statistical programming aspects of the protocol and the clinical development program
• Ensure high quality is built into own deliverables and those of other programmers
• Program independently with high efficiency and quality
• Write and/or implement specifications and oversee completeness of relevant documentation
• Contribute to development of best practices to improve quality, efficiency, and effectiveness
• Ensure compliance with standards and automation usage
• Plan and support team activities and tasks
• Communicate and escalate risks within assigned studies and/or projects
• Work proactively with study team members including Statistician, Lead Programmer, Data Manager and Study Leader
• Act as a client-facing consultant establishing a high-trust environment with client counterparts

Principal Statistical Programmer Consultant – Oncology

• Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
• Produce data listings, summary tables, and graphics for interim and final analyses
• Integrate data across studies within a project and validate analysis datasets
• Test, document, review, and validate all programs according to department guidelines
• Coordinate data transfer and programming standards with CROs and vendors and validate vendor-delivered TFLs and datasets
• Collaborate with other Biometrics functions on clinical trial data analysis activities
• Execute ad-hoc requests, manuscripts, posters, and presentations
• Serve as client-facing principal statistical programming consultant working directly for a single sponsor while supported by ClinChoice

Principal Statistical Programmer Consultant

• Lead and support all statistical programming activities aligned with project strategies
• Use R to create high-quality clinical deliverables and validate outputs using SAS
• Develop Shiny Apps, and R packages; work on modern R framework for app building
• Develop Tables, Listings, and Figures (TLFs) using R
• Author and maintain reusable R macros/functions
• Validate R-based outputs and deliverables against SAS results or legacy code
• Customize outputs and visualizations based on statistical analysis plans and audience requirements
• Take ownership of programming deliverables for clinical studies or projects
• Actively contribute to process improvement, programming standards, and best practices
• Ensure compliance with CDISC standards and maximize automation and reusable code
• Coordinate programming activities, anticipate resource needs, and support timelines
• Proactively identify and communicate risks or issues related to assigned studies/projects

Principal R Programmer

• This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation spanning all client therapeutic areas except oncology.
• The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan.
• The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.
• Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
• Ensure programmatic traceability from data source to analysis/modeling result
• Support the development of programming standards to enable efficient and high-quality production of programming deliverables.

Associate Director, Programming

Principal Statistical Programmer Consultant – Oncology

Principal Statistical Programmer Consultant

Principal R Programmer

1093#Senior Statistical Programmer, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ)