Clinical Outcomes Solutions

• Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP. • Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards, conducting end of trial summarization of risk management activities for inclusion to Clinical study report. • Drafts and oversee RBQM system set up specifications. • Perform the execution and review of the Study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks. • Raise signal and issues in RBQM systems and raise actions as appropriate in RBQM system. • Delivers timely high-quality analytics and supporting RBQM leads in communication to the cross-functional study team to identify resolution. • Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics in the RBQM system. • Perform QC study setup in RBQM system vs RBQM system specifications, if required. • Act as RBQM programmer on set up of KRIs, QTLs, data quality assessments as well as visualizations in the RBQM system, if required. • Perform the maintenance of the Risk-Based Quality Management (RBQM) system based on RBQM Plan requirements, data sources and structure. • Ensure appropriate status and process documentation are produced and maintained during the study. • Communicate and/or escalate serious risks and issues to the RBQM Lead, study team and/or management and Quality, as needed. • Ensure inspection readiness for clinical risk management and centralized monitoring activities.

• Provide statistical support for CMC-related studies, including formulation development, stability studies, process validation, and analytical method validation. • Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical strategies. • Design and analyze experiments using linear mixed models, particularly for stability and variability analyses. • Perform statistical modeling, data visualization, and simulations using R programming. • Experience with Bayesian methods preferred. • Ensure quality and compliance with internal standards and regulatory guidelines (e.g., FDA, EMA, ICH).

• Work closely with client's Quantitative Sciences (QS) staff to support program needs in a timely manner. • Perform end-to-end data analyses, from hypotheses formulation, experimental design, writing analysis plans, data cleaning, executing analysis, and preparing reports and documentation. • Strengthen client’s advanced analytics toolkit by identifying and applying emerging techniques, as well as by advancing the state of the art and developing novel analysis tools as needed. • Collaboration with QS staff and their cross-functional collaborators to understand disease biology and to identify or develop appropriate goals for data science work (for example identifying sensitive and specific endpoints for segmenting patient population, tracking disease progression, quantifying quality of life, etc.) • Work closely with client's statisticians to ensure statistical issues in data analysis are addressed as needed. • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.

• Provide strategic advice on client projects, working closely with Strategic Consultants and Analysts to define optimal regulatory, clinical, and/or market access strategies. • Develop innovative, tailored solutions by combining established methodologies with novel statistical and analytical approaches. • Lead assigned Strategic Consulting accounts and projects, serving as the primary client contact for consulting engagements. • Build trusted, long-term partnerships with clients and take ownership of their strategic needs. • Contribute to Cytel’s thought leadership in statistical methodology and clinical development strategy. • Identify, develop, and pursue new business opportunities within Strategic Consulting and across Cytel’s broader business units. • Recognize emerging client needs and design solutions that support revenue growth, profitability, and customer satisfaction. • Represent Cytel externally, raising brand awareness and strengthening the company’s position as an industry leader. • Travel regularly and engage directly with senior management and executive-level stakeholders at prospective and existing clients. • Build and leverage strong relationships across internal teams and external client organizations.

• Meetings and communications • Generate SDTM and ADaM specifications • Generate & QC assigned dataset domains • Support submission activities • Generate TLFs (patient profile, interim analysis, annual summary report, final CSR) • Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s) • Handling Data transfers to sponsor (or other designee) • Publication support • Ad hoc tasks/activities requested by sponsor • Writing SAS macros and other utilities and tools • Reviewing documents/specifications/output created by sponsor’s Partner CROs • Maintenance of associated tracking and validation documentation

• Serve as Subject Matter Expert (SME) for Medidata Rave and related Medidata applications (Core Configuration, eLearning Assignment, Reporter Assignment, Local Lab, Safety Gateway, TSDV, Batch Uploader, Imaging), advising and mentoring cross-functional teams across Data Management, Statistical Programming, Clinical Operations, and external partners. • Lead and oversee EDC database builds in Medidata Rave, including CRF design, edit checks, derivations, code lists, user roles, and integrations, ensuring alignment with protocol requirements and industry best practices. • Maintain and govern core EDC configuration standards, reusable libraries, and study design conventions to ensure consistency, quality, and efficiency across all studies. • Maintain and manage Cloud Admin EDC roles, ensuring appropriate access control, compliance, and standardized role usage across studies. • Proactively communicate updates, changes, and potential impacts related to core configuration and Cloud Admin roles to internal teams and stakeholders. • Review, assess, and interpret Medidata release notes, platform updates, revised eLearnings, and Rave reports; evaluate impact on ongoing and upcoming studies. • Translate Medidata system updates and enhancements into clear, actionable guidance and training for study teams. • Act as a primary liaison between key stakeholders, ensuring alignment on EDC design, build standards, timelines, and issue resolution. • Act as a liaison between Data Management and Statistical Programming to ensure data collection strategies support downstream analysis, reporting, and regulatory submission requirements. • Collaborate with business owners of other Medidata applications (e.g., Coder, Safety Gateway, CTMS,, eCOA, Imaging) to support integrated data workflows and a cohesive clinical data ecosystem. • Experience with integrating non Medidata systems such as RBQM, CTMS, IRT, and data cleaning tools with Medidata. • Provide ongoing consultation on EDC best practices, system capabilities, and process improvements to support high-quality, compliant clinical trial execution.

• Our Senior Biostatisticians perform statistical analyses to support clinical trial/marketed product submissions to regulatory agencies. • Providing statistical support to clinical studies. • Participating in the development of study protocols, including participation in study design discussions and sample size calculations. • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications. • Performing statistical analyses and interpreting statistical results. • Preparing clinical study reports, including integrated summaries for submissions. • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions. • Understand and follow FDA regulations which affect the reporting of clinical trial data. • Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros. • Participate in the development of CRFs, edit check specifications, and data validation plans. • Provide review and/or author data transfer specifications for external vendor data. • Collaborate with internal and external functions to ensure meeting project timelines and goals. • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.

• Perform complex medical coding for adverse events, medical history, procedures, and concomitant medications using MedDRA and WHODrug dictionaries. • Review and validate coding performed by other coders to ensure consistency and accuracy. • Identify ambiguous or unclear terms and query clinical sites for clarification. • Maintain coding conventions and ensure alignment with study-specific and sponsor requirements. • Conduct ongoing coding checks during data cleaning cycles and prior to database lock. • Participate in the resolution of coding discrepancies, queries, and coding-related data issues. • Review safety data for coding accuracy in collaboration with medical monitors and safety teams. • Assist in the preparation of coding-related metrics, reports, and quality documentation. • Participate in vendor oversight activities when coding tasks are outsourced. • Stay current with updates to MedDRA and WHODrug dictionaries and communicate relevant changes to project teams. • Work closely with clinical data management to ensure proper term collection and standardization. • Partner with safety teams to support expedited reporting, signal detection, and regulatory submissions. • Support biostatistics and medical writing with queries related to coded terms for analyses and study reports.

• Ensuring Cytel’s vision and unique value proposition are presented through meaningful engagements with prospective customers and tailored client-facing materials. • Driving the expansion of the organization’s client base. • Partnering with existing account teams and operational subject matter experts to drive the sales strategy across a diverse range of companies globally. • Identifying and growing high-potential clients through compelling sales enablement tools, impactful client meetings, and high-quality proposals.

• Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency. • Identify, investigate, and resolve data discrepancies through query management. • Conduct manual and system-driven data reviews in accordance with study protocols and DMPs. • Collaborate with cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities. • Participate in database lock activities and ensure data readiness for interim and final analyses. • Maintain study documentation in compliance with regulatory requirements and internal SOPs. • Manage and maintain user access within clinical data management systems (e.g., Medidata Rave). • Process access requests, modifications, and terminations in accordance with established procedures. • Ensure appropriate role-based access and system permissions are assigned. • Maintain audit-ready documentation related to user access activities. • Support periodic access reviews and compliance checks. • Assist with system user training and troubleshooting as needed.