Clinical Outcomes Solutions

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

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.

Senior Medical Coder

Software Engineer

• 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.

Senior Statistical Programmer, FSP

• 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

Principal Statistical Programmer

• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation.
• This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.
• 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.
• Participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.
• Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation.
• As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late-stage clinical trials.

Senior Statistical Programmer

• Provide scientific and analytical leadership for real-world evidence generation using large healthcare data sources.
• Support the evaluation of real-world clinical and economic outcomes for products.
• Lead the tactical planning, execution, and oversight of RWE studies.
• Ensure the timely delivery of high-quality, scientifically robust research outputs.

Principal Statistical Programmer – FSP-RWE

Clinical Research

• Lead statistical activities for assigned Clinical Trials (Phases 1 to 2) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
• Oversight of more junior Statisticians as required.

Principal Biostatistician

QA Engineer

• Lead and evolve Cytel’s global Quality Assurance strategy in alignment with business growth and regulatory expectations
• Oversee, maintain, and continuously enhance the Quality Management System (QMS)
• Serve as a senior leader during sponsor audits and regulatory inspections
• Drive modernization of QA through adoption of digital tools, automation, and AI-enabled solutions
• Improve consistency and reduce variability in audit readiness, execution, and responses
• Partner closely with operational and functional teams to embed quality into day-to-day execution
• Streamline QA processes to reduce unnecessary burden while maintaining robust compliance
• Build, mentor, and develop a high-performing global QA team

Head of Quality Assurance

Vice President

• Serve as an externally recognized thought leader in clinical development, regulatory strategy, market access strategy, and quantitative clinical methods.
• Provide strategic guidance to clients on optimizing clinical development plans, trial design, decision-making frameworks, and evidence generation.
• Develop new methodologies and thought leadership materials for dissemination through conferences, publications, and webinars.
• Lead business development, account management, and project execution across a broad and growing client portfolio.
• Identify emerging client needs and shape innovative solutions aligned with Cytel’s revenue, quality, and customer satisfaction objectives.
• Act as the primary point of contact for Strategic Design Consulting engagements, developing trusted, long-term partnerships with clients.
• Apply deep clinical development knowledge to design, initiate, and conduct effective clinical studies, integrating novel principles where appropriate.
• Serve as a subject matter expert for assigned accounts and therapeutic areas, collaborating with consultants and associates across Cytel.
• Maintain strong engagement with senior client leadership, regulatory agencies (FDA/EMA), and key opinion leaders to support and refine development strategies.
• Mentor and motivate a high-performing team of consultants and analysts; model excellence in strategic thinking and scientific rigor.
• Represent Cytel across the industry, demonstrating strong interpersonal leadership and the ability to influence stakeholders at all levels.
• Participate in cross-functional collaboration within Cytel’s Strategic Consulting and other business units.

Clinical Executive Consultant – Vice President

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

• Write and maintain code for clinical trial data processes, including data extraction, transformation, and analysis using the multiple programming environment.
• Ensure accurate and timely delivery of clinical trial data by performing data checks, validation, testing, and reconciliation in line with clinical trial timelines and regulatory requirements.
• Work closely with clinical data managers, statisticians, and other stakeholders to design and implement clinical data flow, ensuring compliance with all regulatory requirements.
• Identify, investigate, and resolve any issues that arise within the platform or clinical data programming processes.
• Maintain comprehensive documentation of programming processes, code, and data management workflows for audit and regulatory purposes.
• Contribute to the improvement of programming practices, tools, and templates to streamline clinical programming workflows and enhance efficiency.
• Provide guidance and mentorship to junior programmers, ensuring adherence to best practices and facilitating knowledge sharing within the team.

Senior Clinical Programmer

• Leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials.
• Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
• Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
• Communicate with and/or respond to internal cross-functional teams and client for project specifications, status, issues or inquiries.

Senior Statistical Programmer, FSP – SAS, R

• 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.
• Participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

Senior/Principal Statistical Programmer FSP

• Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
• Oversight of more junior Statisticians as required.

Consultant – Pharmacology

Senior Medical Coder

Senior Statistical Programmer, FSP

Principal Statistical Programmer

Principal Statistical Programmer

Senior Statistical Programmer

Principal Statistical Programmer – FSP-RWE

Principal Biostatistician

Head of Quality Assurance

Clinical Executive Consultant – Vice President

Clinical Data Manager – II

Senior Clinical Programmer

Senior Statistical Programmer, FSP – SAS, R

Senior/Principal Statistical Programmer FSP

Principal Biostatistician, FSP