Jobs at Cytel

Provides clinical data management support for assigned studies, including ongoing data review, discrepancy resolution, query management, database lock preparation, regulatory documentation, and user access administration in Medidata Rave. Collaborates with clinical operations, biostatistics, programming, and medical monitoring teams to ensure accurate, complete, compliant, and analysis-ready clinical trial data.

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.

Develop automation and AI solutions supporting pharmaceutical clinical trials. Interpret requirements, identify workflow improvements, build proof-of-concept tools using R, Shiny, and LLM-supported coding, and mature successful prototypes into validated, documented, reusable solutions. Collaborate with statisticians, programmers, data scientists, and AI leads while ensuring testing, traceability, audit trails, version control, and compliance with regulated clinical development expectations.

Leads moderately complex clinical trial projects, managing teams, client relationships, timelines, scope, budgets, quality, documentation, financial performance, and contractual requirements. Serves as the primary customer contact and communicates project status, forecasts, risks, and changes to sponsors and company management.

The Principal Biostatistician leads clinical studies, provides statistical expertise for trial processes, and collaborates with sponsor teams on HTA submissions.

Lead statistical strategy and delivery for Phase I-IV clinical trials embedded with a pharmaceutical sponsor. Design analyses, support protocol and reporting activities, oversee programming/CRO work, apply SAS/R (R Shiny)/Python and ML/DL methods for analyses and automation, and mentor junior statisticians.

Lead statistical design and analysis for Phase I-IV clinical studies, develop protocols and SAPs, perform efficacy and exploratory analyses, run simulations, apply advanced methods (mixed models, longitudinal), oversee datasets (ADaM/CDISC), use R and SAS for analyses, and provide strategic statistical guidance to cross-functional teams supporting regulatory submissions.

Lead and perform SAS-based data manipulation, analysis, and reporting for Phase I–IV clinical trials; generate and validate SDTM/ADaM datasets and TLFs, perform QC/validation, produce submission documents (define.xml), create ad-hoc reports, support efficacy analyses, communicate with cross-functional teams, and provide study lead duties as needed.

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.

Drive revenue growth across the DACH territory by acquiring and managing customers, leading end-to-end consultative sales cycles, developing target accounts, managing pipelines, exceeding sales targets, and positioning Cytel’s services and solutions. The role includes territory strategy, executive-level client engagement, relationship building, industry events, and collaboration with internal experts and leadership.

Lead or support Phase I-IV clinical trial programming using SAS and CDISC standards to generate and validate SDTM/ADaM datasets, TLFs, and submission documents. Perform production and QC/validation programming, complex ad-hoc reports, and efficacy analyses while coordinating with cross-functional teams and serving as study lead when required.