Cytel

www.cytel.com

3 Jobs

1,556 Employees

About the Company

Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.

Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.

Listed Jobs

Company Name: Cytel
Job Title: Executive Consultant (VP level)
Job Description: Job Title: Executive Consultant (VP level) Role Summary: Lead high‑impact client engagements across pharma, biotech, and device sectors as a senior biostatistician and strategic advisor. Drive scientific excellence, client satisfaction, and business growth through advanced statistical methodologies and innovative trial design solutions. Expectations: • Deliver strategic, evidence‑based advisory at VP level, influencing senior executive decisions. • Own a portfolio of high‑value consulting accounts, achieving revenue and impact targets. • Mentor and elevate internal consulting teams while representing the firm at industry events. • Maintain global regulatory expertise and ensure alignment with client objectives and organizational priorities. Key Responsibilities: • Lead and manage end‑to‑end consulting projects across all development stages. • Build and sustain relationships with C‑suite stakeholders; identify new business opportunities. • Provide thought leadership in adaptive designs, Bayesian methods, model‑informed drug development, and machine learning‑based statistical approaches. • Contribute to methodological innovation and service portfolio evolution. • Represent the organization at conferences, webinars, and publications. • Mentor junior consultants and foster a culture of high performance and collaboration. • Travel (20–30%) for client visits and external engagements as required. Required Skills: • PhD/MD/Master’s in Biostatistics, Mathematics, or related field. • 15+ years of experience in clinical development, consulting, or health research. • Proven expertise in advanced trial design, Bayesian statistics, model‑based drug development, and ML‑based analytics. • Strong knowledge of regulatory interactions (FDA, EMA, etc.) and submission processes. • Strategic thinking, analytical rigor, and problem‑solving in complex, global settings. • Excellent communication, influence, and leadership skills with senior stakeholders. • Entrepreneurial, collaborative, self‑motivated mindset; passion for quantitative science innovation. Required Education & Certifications: • Advanced degree: PhD, MD, MBA, or Master’s in Biostatistics, Mathematics, or related discipline. • Certification in advanced statistical methodology or a recognized professional credential is preferred.

Company Name: Cytel
Job Title: Principal Statistical Programmer - SDTM team
Job Description: **Job Title** Principal Statistical Programmer – SDTM Team **Role Summary** Lead statistical programmer responsible for designing, developing, validating, and maintaining CDISC SDTM/ADaM datasets and related reporting deliverables for multiple clinical trials across therapeutic areas. Provides technical guidance, project leadership, and serves as the primary statistical programming point‑of‑contact for assigned protocols throughout the product lifecycle. **Expectations** - 7‑8 years of biostatistics/statistical programming experience in pharmaceutical/biotech clinical development. - Proven track record leading programming teams and managing cross‑functional project execution. - In‑depth knowledge of CDISC SDTM, ADaM, ICH statistical and clinical reporting guidelines, and statistics. - Strong SAS proficiency in data manipulation, analysis, and output programming. - Project management, stakeholder coordination, and quality assurance expertise. **Key Responsibilities** - Provide technical expertise for statistical programming across all development phases. - Design, develop, validate, and archive SDTM, ADaM, enriched, and post‑processed datasets; create tables, listings, and figures. - Lead, review, and QC programming work of internal and outsourced teams; ensure adherence to SOPs and best practices. - Develop and maintain project plans, resource forecasts, and timelines for assigned protocols. - Serve as primary liaison with statisticians and other project stakeholders to ensure timely, high‑quality deliverables. - Coordinate and coach supplier programming teams; manage vendor interactions. - Design complex programming algorithms, interpret statistical analysis plans, and translate methodology into code. - Produce essential documentation (define.xml, submission documents, programming logs) in compliance with regulatory standards. **Required Skills** - Advanced SAS programming (data step, PROC SQL, PROC REPORT, PROC TABULATE, macro programming). - Expertise in CDISC SDTM/ADaM standards, including current version updates. - Familiarity with ICH GCP, ICH E9, and ICH E3 guidelines. - Strong QC and validation skills for both internal and outsourced programming. - Project management and resource planning capabilities. - Excellent written and oral communication; ability to collaborate with global, cross‑functional teams. - Analytical mindset with strong troubleshooting and problem‑solving abilities. **Required Education & Certifications** - Bachelor’s degree (or equivalent) in Statistics, Computer Science, Mathematics, or related scientific discipline. - Professional certifications (e.g., SAS Certified Advanced Programmer) are beneficial but not mandatory.

Company Name: Cytel
Job Title: Senior Statistical Programmer - Biomarker (FSP remote)
Job Description: **Job Title** Senior Statistical Programmer – Biomarker (FSP Remote) **Role Summary** Execute advanced SAS and R programming to transform, analyze, and visualize biomarker data for global pharmaceutical studies. Draft and maintain analysis-ready datasets, statistical analysis plans, and visual reports. Provide expertise in biomarker strategy design, study coordination, and vendor data reconciliation while ensuring compliance with CDISC standards and regulatory requirements. **Expectations** - Deliver high‑quality, reproducible code for pre‑clinical and clinical biomarker datasets. - Maintain meticulous documentation (code, data dictionaries, QA logs). - Collaborate with R&D, clinical operations, statisticians, and external vendors. - Contribute to study design, biomarker strategy, and regulatory submissions. - Communicate findings clearly to multidisciplinary audiences. **Key Responsibilities** 1. **Data Programming & Analysis** - Write, test, and document SAS and R scripts to clean, transform, and merge raw biomarker data into CDISC‑compliant formats. - Perform descriptive and inferential analyses and generate visualizations. - Create reproducible data audit trails and version control. 2. **Data Management & Quality Assurance** - Manage large, multi‑omics datasets, ensuring integrity, consistency, and traceability. - Coordinate with vendors and laboratories to troubleshoot data issues and reconcile datasets. - Maintain biomarker sample inventory logs and tracking systems. 3. **Study Design & Strategy** - Participate in protocol development, endpoint definition, and statistical analysis plan creation for biomarker studies. - Support development of diagnostic biomarker strategies and validation plans. 4. **Collaboration & Communication** - Liaise with cross‑functional teams (R&D, clinical ops, regulatory) to clarify data specifications. - Prepare and present statistical results, reports, and visualizations to internal and external stakeholders. **Required Skills** - Proficiency in SAS (BASE, PROC, DATA step, PROC SQL) and R (data manipulation, visualization, statistical modeling). - Strong command of CDISC standards (SDTM, ADaM) and experience generating compliant datasets. - SQL database skills for data extraction and QA. - Experience with omics or large, complex datasets (genomics, proteomics) is advantageous. - Excellent documentation, version control (Git/SVN), and QA practices. - Strong analytical reasoning, problem‑solving, and communication abilities. **Required Education & Certifications** - Bachelor’s degree in Statistics, Computer Science, Mathematics, Biostatistics, or closely related field. - Certification in SAS (optional) or equivalent statistical programming credential preferred.