ClinChoice

Software Engineer

• Provide oversight development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
• Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides per CDISC and FDA specifications and guidelines.
• Accountable for oversight of statistical programming deliverables for in-house and outsourced projects.
• Provide technical leadership, problem-solving of moderate to high complexity, and within project timelines while providing high-quality deliverables.
• Independently develop SAS or other programs and specifications for production of output to support study needs, including publications, safety reporting, and ad hoc analyses in a timely fashion.
• Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
• Oversee and manage the work of other junior programmers.
• Develop and/or validate standard macros to automate output production.
• Adhere to company SOPs and department guidelines.
• Work concurrently on multiple projects.
• Troubleshoot technical and project issues.
• Help with the infrastructure development of the department.
• Communicate effectively with internal cross-functional groups and external partners.

Principal Statistical Programmer Consultant – Oncology

Compliance

• Lead and contribute to the preparation, review, and submission of regulatory filings to FDA, EMA, and other authorities.
• Provide hands-on support for regulatory document authoring and compiling, balanced with broader strategic and operational guidance.
• Serve as a primary regulatory contact for clients, offering practical solutions for both development-stage and marketed products.
• Collaborate with global regulatory experts, technical teams, and clients to ensure aligned strategies and timely execution.
• Advise on regulatory requirements, risks, and timelines, helping clients navigate evolving regulatory landscapes.
• Support preparation for and participation in regulatory authority meetings.
• Mentor junior regulatory staff and share best practices across the consulting team.

Regulatory Affairs Manager – Drug Products

Project Manager

• Will report to the Director of Evidence Generation.
• Daily focus on operational excellence of all the post marketing clinical trials.
• Will be responsible for all timelines and execution planning of post marketing Phase 4 trials, RWE, HEOR etc.
• Recruitment timelines and acceleration planning for all studies and projects.
• Support coordination of execution at all levels for evidence generation.
• Someone with PM experience in clinical trials that is great at building trackers and leads without authority.
• Has 2-5 years of clinical trial project management experience.
• Can work in a very fast paced environment and keep track of 8-10 clinical trials at one time.

Evidence Generation Project Manager

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Senior Statistical Programmer Consultant – Oncology

Senior Statistical Programmer Consultant

• 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; test, document, review, and validate all programs according to department guidelines
• Coordinate data transfer and/or programming standards with CROs and vendors; validate analysis datasets and TFLs from vendors
• Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data
• Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations.

Principal Statistical Programmer Consultant

• Lead and support all programming activities per project strategies for hematology studies
• Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs and from scratch for new outputs
• Independently program and review reports and outputs with high efficiency and quality
• Customize outputs and graphics according to delivery specifications under direction of biostatisticians
• Support programming deliveries of clinical studies or projects and ensure compliance with standards and automation usage
• Contribute to development of best practices to improve quality, efficiency, and effectiveness
• Plan and support team activities and tasks and communicate/escalate risks within assigned studies and/or projects

Principal Statistical Programmer Consultant – Hematology

• Lead programming activities across multiple studies, ensuring high-quality and regulatory-compliant deliverables
• Develop, validate, and maintain analysis datasets (SDTM/ADaM), Tables, Listings, and Figures (TLFs) using SAS and R
• Design and implement data visualization dashboards in Power BI to support clinical development teams, safety monitoring, and cross-functional data reviews
• Collaborate closely with biostatistics, data management, clinical operations, and other functional teams to ensure accurate, timely, and efficient programming deliverables
• Contribute to the development, refinement, and documentation of standard macros, templates, and programming processes
• Participate in the review of study protocols, CRFs, and statistical analysis plans (SAPs) to ensure alignment with data reporting and visualization strategies
• Ensure compliance with CDISC standards (SDTM, ADaM) and applicable regulatory requirements (e.g., FDA, EMA)
• Provide technical mentorship and support to junior programmers and contribute to training initiatives
• Lead or contribute to programming activities in support of regulatory submissions (e.g., define.xml, reviewer guides, data packages)
• Enable data-driven insights through interactive visualizations

Senior/Principal R Programmer Consultant

• 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

Senior/Principal Statistical Programmer Consultant

• Support Clients France Regulatory Affairs (RA) team
• Review and approve promotional materials for regulatory compliance
• Evaluate artworks and packaging to ensure alignment with applicable regulations
• Conduct product claim assessments in accordance with EU and French cosmetic/commodities legislation
• Provide support in responding to health authority queries and inspections
• Collaborate closely with marketing, legal, and regulatory stakeholders
• Stay current with regulatory developments, particularly in France and the EU

Regulatory Affairs Consultant

Data Scientist

• Collaborate with Data Management teams to design and implement Data Transfer Specifications (DTS) aligned with client requirements
• Build and maintain ETL pipelines to automate extraction, transformation, and loading of data from multiple EDC platforms (Rave, Veeva, Medrio)
• Develop automation scripts in Python to streamline dashboard refreshes and reporting
• Design and deploy interactive Power BI dashboards integrating EDC systems and external sources (labs, MRI, ECG)
• Construct robust data models to support study-level and subject-level analysis
• Ensure data harmonization, normalization, and validation across datasets
• Apply advanced statistical methods and visualization techniques to analyze complex clinical datasets
• Partner with Data Managers to create tools for eCRF specification generation and customization
• Design and implement relational databases to optimize data storage, retrieval, and integration
• Develop user-friendly web interfaces (HTML, CSS, JavaScript) for internal tool accessibility
• Represent the Data Science team in client-facing meetings and collaborate with business development to identify data science opportunities

Senior Data Scientist

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

• 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

• 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

• 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.

Principal Statistical Programmer Consultant – Oncology

Regulatory Affairs Manager – Drug Products

Evidence Generation Project Manager

Senior Statistical Programmer Consultant – Oncology

Senior Statistical Programmer Consultant

Principal Statistical Programmer Consultant

Principal Statistical Programmer Consultant – Hematology

Senior/Principal R Programmer Consultant

Senior/Principal Statistical Programmer Consultant

Regulatory Affairs Consultant

Senior Data Scientist

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)