Jobs at Cytel

Provides statistical support for Phase I–IV clinical studies, including study design, sample size calculations, protocol development, CRF and data review, SAPs, ADaM specifications, statistical analyses, clinical study reports, and regulatory submissions. Collaborates with clinical, regulatory, programming, pharmaceutical, and biotechnology teams while explaining statistical methods and results to stakeholders.

Supports risk-based quality management for clinical studies by assessing protocol risks, implementing KRIs and QTLs, analyzing clinical trial data, identifying anomalies and issues, maintaining RBQM systems, documenting processes, conducting quality control, and communicating risks to cross-functional study teams. The role also supports inspection readiness and collaborates with programmers on study-specific analytics, visualizations, and system configuration.

Supports project forecasting, invoicing, cash flow, financial system validation, monthly project finance reviews, resource alignment, and reporting. Partners with project managers, finance leaders, and internal teams to identify financial risks, resolve issues, reduce cost overruns, and improve project performance. The role requires financial analysis, organization, communication, and proficiency with Microsoft Excel and Office tools. It is remotely based.

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 the organization’s AI program portfolio, overseeing strategic initiative planning, delivery, governance, prioritization, budgets, risks, and performance. Manages AI competitive intelligence activities, vendors, consultants, and strategic partners. Coordinates cross-functional teams and executive stakeholders, facilitates governance meetings, prepares reports and business cases, and ensures AI programs align with corporate objectives and deliver measurable value.

Perform statistical programming for Phase I–IV clinical trials, including SAS-based data manipulation, analysis, reporting, and production/QC validation. Generate SDTM and ADaM datasets, tables, listings, figures, ad hoc reports, and submission documents. Collaborate with clients and cross-functional teams, support efficacy analyses, troubleshoot issues, and lead programming activities when needed.

Provides statistical support for Phase I–IV clinical studies, including study design, sample size calculations, SAP development, statistical analyses, regulatory submissions, and clinical study reports. Reviews CRFs, data specifications, and validation plans; supports CDISC and ADaM compliance; collaborates with CROs, vendors, and clinical development teams; and contributes to statistical programming standards, SOPs, and work instructions.

Perform and validate SAS programming for Phase I-IV clinical trials, including SDTM and ADaM datasets, efficacy analyses, tables, listings, figures, ad hoc reports, submission documents, and eCRTs. Support safety and efficacy data analysis, QC, troubleshooting, client communications, and cross-functional collaboration. The role requires strong clinical trial programming expertise, CDISC standards knowledge, and pharmaceutical or biotech experience, with oncology or immunology experience preferred.

Leads clinical data management activities for pharmaceutical trials, including EDC builds, CRO oversight, timelines, deliverables, budgets, inspection readiness, audits, governance, SOPs, metrics, and continuous improvement. Partners cross-functionally with clinical operations, statistics, statistical programming, therapeutic area teams, clients, and vendors to ensure high-quality data, regulatory compliance, and on-time database delivery.

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

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.

Leads statistical programming for pharmaceutical clinical trials, including SDTM and ADaM datasets, TLFs, specifications, reviewer’s guides, Define.xml files, and regulatory submissions. Develops, validates, and maintains SAS and R programs; supports oncology analyses, clinical study reports, CRFs, data validation, and vendor transfers. Oversees CRO programming deliverables, maintains programming standards and SOPs, ensures FDA/ICH compliance, and collaborates with clinical, statistical, regulatory, and external teams.

Performs SAS programming, data manipulation, analysis, reporting, and QC for Phase I–IV clinical trials. Generates and validates SDTM and ADaM datasets, tables, listings, figures, ad hoc reports, submission documents, and eCRTs. Supports efficacy and safety analyses, communicates with cross-functional teams and clients, contributes to study leadership, and delivers compliant outputs within challenging timelines.

Lead real-world evidence biostatistical analyses using large-scale healthcare data to support clinical development, regulatory strategy, HEOR, and payer decisions. Design observational studies and target trial emulations, apply causal inference, statistical learning, machine learning, and NLP, and build reproducible Python/R workflows. Collaborate with clinical, epidemiology, data engineering, and HEOR teams while translating findings for technical and non-technical stakeholders. Support regulatory submissions, governance, audits, and scientific dissemination.

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.

Independently leads statistical programming for pharmaceutical clinical development studies. Develops and validates SAS and R programs, SDTM and ADaM datasets, specifications, tables, listings, graphs, and regulatory submission deliverables. Oversees CRO programming work, supports clinical study reports and FDA submissions, maintains programming standards, contributes to CRFs and validation plans, and collaborates with clinical, regulatory, vendor, and development teams.

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.