Jobs at ClinChoice

Supports clinical trial statistical programming under senior guidance, including developing and validating datasets, tables, figures, listings, and CDISC-compliant regulatory submission deliverables. Uses SAS and/or R to process clinical data, contribute to SDTM and ADaM datasets, maintain specifications and documentation, perform quality checks, and resolve programming issues. Collaborates with biostatisticians, data managers, and cross-functional teams while developing expertise in clinical research standards and statistical programming.

Manage the development, implementation, operation, monitoring, and assessment of REMS and U.S. risk management programs. Coordinate governance, stakeholders, vendors, budgets, compliance documentation, audits, CAPAs, FDA correspondence, reporting, risk mitigation, and inspection readiness. Support launches, program transitions, operational inquiries, and effectiveness assessments while maintaining controlled workflows and regulatory records.

Leads statistical programming for clinical trials, developing and reviewing SAS programs, datasets, tables, listings, and figures. Supports SDTM/ADaM standards and regulatory submissions, reviews specifications and outputs, manages deliverables and timelines, collaborates with clinical teams, and provides technical guidance and mentorship to statistical programmers. Requires strong knowledge of clinical development, CDISC, ICH, Good Clinical Practices, and regulatory requirements.

Leads North American regulatory affairs for pharmaceutical and biotech clients, developing global regulatory strategies, overseeing submissions, ensuring compliance, advising on FDA and health authority requirements, and managing regulatory projects. The role includes authoring and compiling IND, CTA, BLA, MAA, and NDA documents, monitoring regulatory changes, mentoring and hiring staff, supporting client presentations, and contributing to department growth and digital process solutions.

Leads clinical pharmacology and PK/PD study design, protocol development, modeling and simulation, data analysis, regulatory reporting, and client collaboration. Uses pharmacokinetic software to support clinical trials, publications, and regulatory submissions. Provides scientific leadership, mentors junior pharmacologists, manages multiple projects, and applies current clinical pharmacology practices across pharmaceutical and biotechnology programs.

Leads statistical programming activities for clinical trials, including programming and validating datasets, tables, figures, listings, and electronic submissions. Oversees CRO and vendor deliverables, supports CDISC-compliant submissions, contributes to clinical documentation and standards, performs exploratory analyses, and provides technical guidance to programmers. Collaborates with cross-functional teams to ensure high-quality, timely deliverables.

Manages multiple clinical trials through site selection, study start-up, monitoring, data verification, safety reporting, site closeout, and regulatory compliance. Trains site staff, oversees investigational products and study documentation, supports submissions and CRF development, resolves data queries, and supervises junior CRAs. The role focuses on oncology and medical device trials, including gastrointestinal oncology and HIFU therapy, with both remote and on-site monitoring.

Leads and supports statistical programming for clinical studies within a CRO environment. Implements protocol and clinical development programming, prepares specifications and documentation, ensures quality and regulatory compliance, supports standards and automation, coordinates team activities, escalates risks, and collaborates with statisticians, programmers, data managers, and study leaders.

Provides regional safety oversight for consumer products across their lifecycle, including development and post-market surveillance. Evaluates safety data, identifies risks and signals, develops safety assessments, and communicates clinical insights. Partners with the Regional Medical Safety Officer and cross-functional teams across regulatory, quality, R&D, and local pharmacovigilance. Supports safety deliverables, timelines, benefit-risk evaluations, and complex data analysis while representing safety decisions in regional meetings.

Assist with checking and completing 2025 and 2026 finance files, as well as filing and printing documents. The role requires an honest, responsible, computer-literate accountancy student who can work with minimal supervision and demonstrate initiative.

Manage 2-3 clinical trials with site start-up, on-site and remote monitoring, SDV, CRF review, safety reporting, investigational product and trial material management, study closeout, site training, and supervision/mentoring of junior CRAs. Support submissions, CRF design, and quality control for oncology and complex trials.

Lead statistical activities for clinical studies, including protocol development, sample size calculations, randomization, statistical analysis plans, data quality oversight, and reporting. Ensure the validity, accuracy, consistency, and timeliness of analyses, tables, figures, listings, and statistical methods sections. Provide statistical guidance, mentor junior statisticians, coordinate assignments, review work, and support high-quality delivery across pharmaceutical, biotechnology, medical device, and consumer health projects.

Leads statistical activities for clinical trials across pharmaceutical, biotech, medical device, and consumer health projects. Acts as lead statistician, overseeing statistical strategy, SAPs, analysis database specifications, clinical study report sections, output interpretation, quality, and regulatory compliance. Collaborates with clinical, programming, data management, and regulatory teams; guides statistical programmers; communicates results and risks to technical and non-technical stakeholders; and ensures adherence to FDA, ICH, GCP, and company SOPs.

Leads and supports statistical programming deliveries for oncology clinical studies, implementing protocol and clinical development programming, producing compliant documentation, ensuring quality and standards adherence, managing concurrent activities, and coordinating with statisticians, programmers, data managers, and study leaders. The role independently delivers high-quality programming, escalates risks, supports team planning, and contributes to process improvements within a CRO client-facing environment.

Leads and supports statistical programming deliverables for oncology clinical studies, implementing protocol and clinical development requirements. Independently programs high-quality outputs, develops specifications, oversees documentation, ensures standards and automation compliance, supports team activities, manages risks, and collaborates with statisticians, lead programmers, data managers, and study leaders. The role also contributes to programming best practices and requires strong knowledge of clinical research, drug development, ICH, Good Clinical Practices, and regulatory requirements.

Leads statistical activities for oncology clinical trials, serving as lead statistician for study strategy and deliverables. Authors and reviews Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Interprets analysis outputs, ensures regulatory compliance, collaborates with clinical, programming, data management, and regulatory teams, and guides statistical programmers. Communicates statistical results and risks to technical and non-technical stakeholders.

Develop and validate SDTM and ADaM datasets, statistical programming specifications, tables, listings, figures, patient profiles, and FDA submission packages using SAS. Support clinical study reports and integrated safety and efficacy summaries while collaborating with statisticians and cross-functional teams. Lead programming activities, mentor team members, interpret regulatory requirements, resolve programming challenges, and review deliverables for quality and consistency.

Provides regional safety oversight for consumer products throughout their life cycles, including development and post-market surveillance. Evaluates safety data from reports, literature, and other sources; identifies and manages risks; develops safety assessments; and communicates clinical insights to cross-functional stakeholders. Partners with regional medical safety and pharmacovigilance teams, supports safety deliverables, manages complex product portfolios, analyzes large datasets, and ensures compliance with timelines and SOPs.

Responsible for managing the end-to-end artwork development process for packaging and labeling, ensuring timely delivery and compliance. Coordinate with teams and vendors, drive improvements, and supervise controllers.

Manage the end-to-end artwork development process for packaging and labeling, ensuring quality compliance, coordinating teams, and driving improvements.