ClinChoice

Data Scientist

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support TLF (Tables, Listings, Figures) generation in R or SAS as needed.
• Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting.
• Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
• Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA).
• Contribute to programming workflows, documentation, and version control best practices.
• Support automation initiatives and R-based pipeline development.
• Utilize SAS for legacy studies or where SAS support is required.

Principal Data Scientist Consultant, R, CDISC

• Lead Data management activities and ensure study deliverables meet timelines and quality standards.
• Review of Clinical research documents (e.g. protocols, Case Report Forms).
• Create and review electronic Case Report Form (eCRF) specifications.
• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
• Develop edit rules/checks, query logic and query messages.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
• Create and provide training to the clinical team and sites.
• Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
• Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
• Coordinate the archiving of study databases and related documents.
• Create Data Transfer Specifications and perform external vendor reconciliation.
• Perform SAE reconciliation.
• Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.

Data Manager – Inhouse

Clinical Operations

• Organizes and participates in Monitor’s and Investigator’s Meetings.
• Performs, if necessary, co-monitoring visits for the assigned clinical projects.
• Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
• May act as Feasibility Associate (FEA) after appropriate and documented training.
• Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
• Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
• Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
• Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
• Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
• Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
• Regularly track all expenditure and review for consistency with trial budgets.
• Organize quality check of filing of key study documentation.
• Ensure all administrative close-out procedures are completed.
• Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Clinical Project Manager II

Clinical Research

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Responsible for validity of analysis and explore alternative analysis strategies as needed.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Principal Biostatistician Consultant, Oncology – Late Phase

Business Development Rep

• Identify, assess, and develop new global full clinical service strategic plans.
• Implement realistic and actionable plans to achieve or exceed annual revenue goals that align with the company’s growth objective.
• Actively identify and secure new business opportunities and/or grow/expand services with existing clients.
• Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations, including their Clinical Operations function, Outsourcing function, Procurement function, and C-Suite executives.
• Represent Company at key conferences, trade shows, and networking events to learn and monitor industry trends and competitor activities.
• Maintain all pipeline data promptly from prospecting to closing contracts in company CRM database.

Director, Business Development

General

• Provide statistical support for Medical Affairs studies, including observational studies, real-world evidence (RWE) studies, and post-marketing and Phase IV studies
• Contribute to study design, protocol development, and statistical analysis plans (SAPs)
• Perform and/or oversee statistical analyses and ensure accuracy and quality of outputs
• Collaborate with Medical Affairs, Clinical, Epidemiology, and HEOR teams
• Interpret study results and contribute to clinical study reports, publications, and presentations
• Ensure compliance with regulatory and internal standards
• Support publication strategy and scientific communication activities
• Mentor junior statisticians, if applicable

Senior/Principal Statistician – Medical Affairs

Software Engineer

• Lead programming activities for oncology clinical trials across multiple studies.
• Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
• Provide SAS programming expertise to support complex data derivations and analyses.
• Review and ensure traceability, consistency, and quality of all programming deliverables.
• Act as programming lead for assigned studies, managing timelines and deliverables.
• Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

Senior Statistical Programmer Consultant, Oncology

• lead cross-functional teams and oversee the execution of complex clinical trials
• ensure successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements
• manage and coordinate assigned clinical projects
• manage all project-specific services required by the Sponsor
• interact with Sponsor and Investigators and properly coordinate project team members
• keep abreast of all scientific, regulatory, and operational aspects relevant to clinical projects
• collect and manage study data documentation
• assure proper timelines of assigned projects
• manage the budget for the project
• monitor workload and performance of project team

Senior Clinical Project Manager

Consultant

Principal Statistician Consultant – Respiratory & Immunology

Manager

• Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs.
• Capacity for independent programming and review of reports and outputs.
• Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians.
• Responsible for supporting the Programming deliveries of a clinical study or project.
• Programs independently with high efficiency and quality.
• 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.

Manager, Statistical Programming

• Partner with medical for publication strategies, HEOR or economic modeling inputs
• Provide statistical expertise in analyses using external control and/or synthetic control, meta-analyses, and causal inference analyses, e.g. propensity score matching method
• Contribute to manuscripts, abstracts and presentations
• Collaborate with HEOR to align analyses with HTA agency expectations
• Review protocols for real world evidence studies
• Work with statistical programmers to conduct ad hoc analyses; Conduct quality review of statistical analyses
• Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
• Review relevant medical literature
• Write statistical analysis plans
• Develop TLF shells and review programming specs

Principal Biostatistician Consultant – Medical Affairs, Commercial

Data Analyst

• Lead development of analysis specifications, develop programs, and conduct analyses while providing technical guidance for Real World Data (RWD) research.
• Ensure quality standards and methodological rigor across projects through development of patient cohorts and validation of key variables.
• Leadership of RWD analysis strategy and execution.
• Lead development of technical specifications and study methodology.
• Statistical programming proficiency (R, SAS, SQL., Python).
• Oversight of quality control processes.
• Cross-functional team collaboration.
• Management of project timelines and deliverables.
• Development of best practices and standards.
• Demonstrated ability to communicate complex analyses to non-technical stakeholders.

Senior Real-World Data Analytics Consultant, Senior Data Scientist Consultant

Project Manager

• Organizes and participates in Monitor’s and Investigator’s Meetings.
• Performs, if necessary, co-monitoring visits for the assigned clinical projects.
• Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
• May act as Feasibility Associate (FEA) after appropriate and documented training.
• Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
• Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
• Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
• Assess scope of work and timelines against contractual agreements and identify change orders proactively.
• Manage any deviations on resources and hours spent on the project to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
• Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
• Regularly track all expenditure and review for consistency with trial budgets.
• Organize quality check of filing of key study documentation.
• Ensure all administrative close-out procedures are completed.
• Follow and comply with the Company’s QMS, ISMS and PIMS requirements.