Clinical Outcomes Solutions

Business Analyst

• 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.

Clinical Insights Analyst I

Data Scientist

• 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.

Clinical Data Manager II

Clinical Research

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
• Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Principal Biostatistician – Vaccines

• 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).

Principal Biostatistician – Chemistry, Manufacturing and Control

Accounting Manager

• lead key areas of accounting, including revenue recognition
• lead key strategic accounting initiatives
• enhance the company’s internal controls and processes following Oracle Fusion ERP implementation
• play a key role in day-to-day operations through auditing of project set-up
• perform customer contract reviews and other tasks in support of the revenue recognition process
• collaborate strongly with internal stakeholders, external partners, and senior leadership

Associate Director, Accounting

Director

• Will be a lead statistician on individual studies, across related studies, and for integrated summaries.
• Design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician.
• Responsible for all statistical aspects of study design, study analysis, validation, and documentation.
• Provide timely and scientifically sound statistical expertise to clinical development projects.
• Develop and execute statistical strategy, design, and analyses for clinical trials.
• Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

Associate Director, Biostatistics

Software Engineer

• 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

Principal Statistical Programmer

• Providing support to the Epidemiology team by preparing Real World data, advising on data analytic strategies, and supporting stakeholders in various epidemiology analytic activities
• Programming and conducting statistical analysis under the direction and supervision of epidemiologists/statisticians including data coding, creation of algorithms, linkage of datasets, and use of statistical packages or platforms
• Supporting statistical programming to generate innovative means of data standardization, visualization, and reporting of observational data
• Supporting Medical Affairs (e.g. observational studies leveraging RWD); Global Patient Safety and Risk Management (e.g., analysis to obtain background rates) for the development of regulatory/safety documents, and Clinical Development (e.g.; assessment of patient populations/ protocol feasibility)
• The position will partner with Epidemiologists to manage relationships with internal and external stakeholders
• Being able to prioritize and manage work across multiple projects and stakeholders
• Providing strong communication to ensure successful and timely project delivery
• Solving technical problems with experience and expertise

Principal Statistical Programmer – FSP, RWD/EPI

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

Senior Statistical Programmer, FSP

Medical Billing and Coding

• 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.

Medical Coder

Consultant

• Serve as an externally recognized expert in Quantitative Clinical Pharmacology, Pop-PK/PK-PD modeling, MIDD, and quantitative regulatory strategies.
• Lead the development and dissemination of innovative methodologies, contributing to Cytel’s scientific leadership through publications, conference presentations, and webinars.
• Provide high-level strategic guidance to clients on clinical development plans, regulatory and market access pathways, trial design optimization, and quantitative decision-making.
• Act as the primary point of contact for major Strategic Consulting accounts, ensuring delivery excellence and long-term partnership development.
• Identify and pursue new business opportunities across Cytel’s consulting and analytics offerings, shaping solutions that meet revenue, profitability, and client satisfaction objectives.
• Build and maintain relationships with senior stakeholders, including regulatory agencies (e.g., FDA, EMA), key opinion leaders, and executive-level client personnel.
• Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis (NCA), and broader QPP analytical activities.
• Provide mentorship, technical oversight, and direction to consultants and analysts, building a high-performing quantitative team.
• Support non-QPP engagements when needed, such as statistical design, adaptive/Bayesian methodologies, simulation-based planning, or data science initiatives.
• Work closely with Cytel’s business developers, statisticians, software teams, and data scientists to deliver integrated, high-value solutions.
• Represent QPP expertise within multidisciplinary engagements, ensuring strategic alignment and scientific rigor.
• Travel as required to engage with clients and internal stakeholders.

Consultant – Pharmacology

Senior Medical Coder

• Leverage advanced SAS programming skills and proficiency in CDISC standards to support or lead clinical trials.
• Generate and validate statistical programming deliverables in Early Development Statistics.
• Perform data manipulation, analysis and reporting of clinical trial data.
• Collaborate with internal cross-functional teams and clients for project specifications, status, issues or inquiries.

• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you
• The Principal Statistical Programmer works independently with only concept level instruction and very little supervision
• Tracks progress and provides expert technical support to team members
• Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
• Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelines