Your responsibilities will include but not limited to:
- Coordinate and track clinical data standards and statistical programming activities across clinical programs
- Support operational transition activities including organizing workshop for knowledge transfer, identifying/maintaining procedural documents, training planning and creating checklist and documentation inventory.
- Support inspection readiness and ensure appropriate project documentation is maintained.
- Develop and maintain task lists, process flow, project plans, timelines, resource forecasts, risk logs, and communication plans.
- Help to build internal portal to support future activities.
- Support to update SOPs as needed.
- Facilitate cross-functional project meetings and communicate project status to internal teams and sponsor stakeholders.
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field.
- 5+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments.
- 2+ years of project management or study management experience.
- Working knowledge of the clinical development lifecycle.
- Deep understanding of Clinical/Statistical Programming (Data ingestion, SDTM, ADaM, TFLs, Ad Hocs, ISS/ISE, etc.)
- Understanding of the relationship between source/clinical data, SDTM datasets, ADaM datasets, tables, listings, and figures.
- Experience coordinating cross-functional teams, including Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
Strong organizational, communication, stakeholder management, and problem-solving skills.
Skills Required
- Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
- 5+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments
- 2+ years of project management or study management experience
- Working knowledge of the clinical development lifecycle
- Deep understanding of clinical and statistical programming, including data ingestion, SDTM, ADaM, TFLs, ad hoc analyses, ISS, and ISE
- Understanding of relationships among source or clinical data, SDTM datasets, ADaM datasets, tables, listings, and figures
- Experience coordinating cross-functional teams, including Data Management, Biostatistics, Statistical Programming, and Clinical Operations
- Strong organizational, communication, stakeholder management, and problem-solving skills
Cytel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
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Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
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Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.
Cytel Insights
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
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