ClinChoice

• 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.

• 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

Role Description ClinChoice is searching for a Clinical R Programmer/Principal Data Scientist Consultant to join one of our clients. We are seeking a Principal Data Scientist Consultant with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADaM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams. - 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. Qualifications - Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. - 4–6+ years of experience in clinical programming, with a strong focus on R. - Proven experience in creating SDTM and ADaM datasets using R. - Working knowledge of SAS programming. - Solid understanding of CDISC standards (SDTM, ADaM). - Experience with clinical trial data, regulatory submissions, and QC processes. - Strong analytical, problem-solving, and documentation skills. Requirements - Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits. - Understanding of R Markdown, Shiny apps, or reproducible reporting tools. - Exposure to GxP validation, version control (Git), and automated workflows. - Experience working in a CRO or pharmaceutical environment. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Role Description - Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. - Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. - Serves as the primary liaison between clients, vendors, and project teams. - Promotes team communication and cross functional collaboration in order to promote team spirit. - Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. - Coordinates and leads team meetings. - Creates and distributes agendas and minutes. - Generates and maintains timelines, milestones, and action items. - Manages project financials; estimates monthly accruals and initiates timely invoice generation. - Identifies change orders items. - Oversees issues and facilitates issues resolution, and escalates, when needed. - Identify risks, mitigation, maintenance and resolution. - Ensures training required internally and by sponsor is completed. - Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. - Provides performance feedback for project team and managers. - Supports business development activities (RFPs and RFIs) and governance activities, when required. - Performs other tasks as assigned by Sr. PM staff. Qualifications - Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. - Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. - Possesses solid knowledge of Biometrics services and inter-dependencies. - Knowledge of FDA regulations, drug development and PM processes. - Good understanding of ICH/GCP guidelines. - Strong communication skills, both oral and written. - Strong team player and interpersonal skills and customer focused. - Proficiency in Microsoft Word, Excel, Power Point, Outlook and MS Project. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Role Description ClinChoice is searching for a Principal Clinical Data Scientist Consultant – R Programmer to join one of our clients. We are seeking a Principal Clinical Data Scientist to join our Scientific Computing Technology group, which builds the open-source tools, R packages, SAS macros, and computing systems that power clinical programming, data management, and biostatistics across the organization. Reporting to the Director of Statistical Programming, this role blends hands-on clinical deliverables with contributions to the open-source and internal tooling that supports the wider clinical technical community. The ideal candidate has strong R skills, deep clinical programming experience, working Python familiarity, and an interest in modern, reproducible workflows. This position is open to remote candidates. Key Responsibilities - Develop, validate, and maintain SDTM and ADaM datasets in R — using admiral and the broader pharmaverse — following CDISC standards. - Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs. - Perform Pinnacle21 validation, resolve findings, and refine specifications to ensure CDISC compliance and submission readiness. - Write efficient, reproducible, well-structured R code for clinical data analysis and reporting. - Contribute to open-source and internal tooling — including R Shiny / teal modules, R packages, SAS macros, and Python utilities — used by clinical programming, data management, and biostatistics teams. - Partner with statisticians, data managers, and clinical teams to translate programming requirements into reliable deliverables. - Perform QC, reconcile data issues, and ensure outputs meet regulatory expectations (e.g., FDA, EMA). - Support automation, pipeline development, and version-controlled workflows. - Use SAS for legacy studies or where SAS support is needed. Qualifications - Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field. - 5+ years in clinical programming, with a strong focus on R. - Proven experience producing SDTM and ADaM datasets in R, including hands-on use of admiral. - Experience with Pinnacle21 validation and remediation. - Working knowledge of SAS programming. - Working knowledge of Python for analytics, scripting, or tooling. - Solid understanding of CDISC standards (SDTM, ADaM) and metadata-driven programming. - Experience with clinical trial data, regulatory submissions, and QC processes. - Strong analytical, problem-solving, and documentation skills. Preferred Qualifications - Broader pharmaverse experience (e.g., tidyCDISC, rtables) and tidyverse fluency. - Experience building or contributing to R Shiny apps, teal modules, or R packages used by other teams. - Exposure to AI/ML tooling in a clinical or programming context. - Real-World Evidence (RWE) experience — e.g., mapping Flatiron or claims/EHR data into CDISC-aligned structures. - R Markdown, Quarto, or other reproducible reporting workflows. - GxP validation, Git-based version control, and CI/CD or automated workflows. - CRO or pharmaceutical industry experience. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

• 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.

Role Description We have a fantastic opportunity available with ClinChoice, which would be ideal for a motivated individual interested in developing their sales and business development experience within clinical trials. The successful candidate will support the Business Development Directors with: - Lead generation - Opportunity assessment - Creating new accounts - Growing existing accounts This role will be remote within the Greater London / Cambridge / Home Counties area. Join our team and help us deliver clinical trials that will improve patients’ lives. Qualifications - A degree in life sciences, business or similar area - 2 years of experience within an Inside Sales, Business Development or Account Management-type role, ideally within the pharmaceutical or CRO industry - Excellent communication (written and verbal) and interpersonal skills - Knowledge of the drug development and clinical trial process - A passion for building client relationships - Resourcefulness - An inquisitive mind Requirements The Application Process: - Once you have submitted your CV, you will receive an acknowledgement that we received it. - If you have the requirements we need, you will be invited for a phone interview as the first step. - Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our Company Ethos: - Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. - Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. - Close management and training is the core instrument to develop and maintain highly-qualified personnel. - The continuous training keeps the resources qualified in terms of competence and expertise. - We recognize and celebrate diversity and inclusivity as our strength.

Role Description We are looking for a dynamic person to join our in-house team as a Business Development Manager or Associate Manager in the United Kingdom, preferably in the Greater London/Cambridgeshire area. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies. - Identify, assess, and pursue new business opportunities. - Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations. - Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans. - Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates. - Work to exceed revenue targets that align with the company's growth objectives. Qualifications - 2+ years of sales and account management experience. - Established a network of decision-makers in the life-sciences industry. - Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders. - Strong negotiation skills with a proven track record of closing complex business deals. - Persuasive and compelling presentation and communication skills, both written and verbal. - Ability to interpret business challenges and present quick and responsive high-level solutions. - Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle. - Positive employer and client references. - BA, MBA, or equivalent experience. Requirements - Previous experience selling full service CRO services is required. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

• 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.

• 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.