Jobs at Cytel

Provides statistical strategy and biostatistical oversight for pharmaceutical clinical trials, including protocols, SAPs, clinical study reports, regulatory documentation, analyses, randomization, and vendor deliverables. Develops innovative statistical methodologies and tools, supports clinical development programs, reviews data management documentation, and contributes to cross-functional standards and infrastructure initiatives.

Leads statistical programming for pharmaceutical clinical development programs. Develops and validates SAS or R programs, SDTM and ADaM datasets, tables, listings, figures, specifications, and regulatory submission deliverables. Oversees CRO programming work, supports clinical study reports and FDA submissions, maintains programming standards, contributes to CRF and validation planning, and collaborates with clinical, vendor, and regulatory teams.

Leads complex clinical trial statistical programming using SAS, including TLFs, SDTM and ADaM datasets, Define.xml, regulatory submissions, documentation, quality control, and global utility development. Provides technical and project leadership, ensures compliance with SOPs and FDA/ICH/GCP regulations, supports interactions with regulators and external partners, and independently briefs management on progress and issues.

Lead biostatistical support for Phase I–IV clinical trials, including study design, sample size calculations, exploratory and efficacy analyses, simulation studies, statistical analysis plans, regulatory submissions, and interpretation of results. Provide strategic guidance to cross-functional teams, oversee vendor-supported work, apply advanced statistical methods, and communicate technical findings clearly to technical and non-technical stakeholders.

Leads statistical programming for pharmaceutical clinical development studies, generating SDTM and ADaM datasets, specifications, tables, listings, graphs, and regulatory documentation. Develops, validates, and maintains SAS and R programs; supports FDA submissions, clinical study reports, DSURs, publications, and data transfers. Oversees programming deliverables, maintains standards and macros, collaborates with CROs and vendors, and provides technical leadership and mentorship.

Manage sponsor-dedicated clinical development projects for a pharmaceutical client. Coordinate clinical data standards and statistical programming, operational transitions, documentation, inspection readiness, SOP updates, project plans, risks, resources, and stakeholder communications. Facilitate cross-functional collaboration among Data Management, Biostatistics, Statistical Programming, and Clinical Operations teams while supporting process optimization and operational transformation.

Performs statistical programming for Phase I-IV clinical trials, including clinical data manipulation, analysis, reporting, dataset and analysis file creation, TLF development and validation, ad hoc reporting, efficacy analysis, and submission package preparation. The role is designed for a recent graduate and involves working within a global pharmaceutical client team while following established processes and meeting deadlines.

Develops, validates, and maintains Power BI clinical, safety, and operational dashboards for trial monitoring and data review. Creates visualization standards, reusable components, specifications, and quality-control processes. Translates study needs into reliable dashboard solutions and collaborates with Statistics, Data Management, Clinical Operations, Safety, Standards, and external partners. Applies Power BI, SAS, Python, R, automation, and emerging analytics technologies across the clinical data lifecycle, using CDISC standards including CDASH, SDTM, and ADaM.

Provides expert leadership and oversight of CDISC standards across clinical studies and regulatory submissions. Reviews SDTM and ADaM datasets, annotated CRFs, define.xml files, Reviewer's Guides, and submission packages for compliance, traceability, and quality. Advises cross-functional teams and CROs, supports standards governance, develops documentation and training, mentors programmers, and improves global programming processes and submission readiness.

Lead statistical activities for Phase II–III clinical trials from protocol design through reporting. Responsibilities include SAP development, sample size calculations, statistical analysis, TLF review, database lock and submission support, regulatory responses, vendor oversight, and cross-functional collaboration. Use SAS and/or R for analyses, modeling, simulation, exploratory work, and quality control. Coordinate statistical activities across studies and apply adaptive, group sequential, count-data, machine learning, and deep learning methods.

Supports epidemiology and real-world evidence studies by preparing claims and EHR data, developing analytical databases, programming statistical analyses, creating algorithms, linking datasets, and producing tables, figures, reports, and presentations. Partners with epidemiologists, statisticians, vendors, clients, and internal stakeholders across Medical Affairs, Patient Safety, Risk Management, and Clinical Development. Requires expertise in SQL, SAS or R, RWE data sources, applied statistics, and project management.

Leads portfolio strategy, solution architecture, commercial growth, and delivery alignment for complex life sciences services. Partners with business development, marketing, sales, and functional experts to shape opportunities, design scalable offerings, support proposals, and improve profitability. Oversees portfolio governance, client outcomes, forecasting, scope management, and sales-to-delivery handoffs. Represents the organization with strategic clients and through industry thought leadership.

Provides technical and functional leadership for epidemiological and real-world evidence statistical programming. Leads hands-on development and validation of SAS and R programs, analysis datasets, tables, figures, and reproducible workflows using healthcare data. Mentors programmers, oversees internal and CRO deliverables, establishes standards and quality processes, supports regulatory and scientific outputs, and collaborates with epidemiologists, statisticians, and data scientists across projects and therapeutic areas.