Sponsor-dedicated:
Your responsibilities will include:
- Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
- Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by external resources.
- Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
- Review the randomization procedures and oversight of the production of randomization lists.
- Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
- Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
- Produce innovative tools and methodologies for statistical analysis through literature review.
- Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.
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:
- Master’s degree in Statistics or a related field, with 7+ years of experience in statistical analysis within the biotech/pharmaceutical industry. PhD preferred.
- Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs. Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
- Strong statistical programming skills (R, SAS, Python).
- Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.
- Strong vendor management experience.
- Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
- Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.
- Demonstrated ability to work independently, take ownership and be accountable for study and program-level statistical activities and deliverables
Skills Required
- Master’s degree in Statistics or a related field
- 7+ years of statistical analysis experience within the biotech or pharmaceutical industry
- PhD degree
- Experience with a broad range of statistical approaches
- Experience proposing novel statistical approaches to accelerate clinical programs
- Knowledge of machine learning and artificial intelligence developments
- Understanding of regulatory guidelines for drug development, regulatory submissions, and statistical practice
- Strong statistical programming skills in R, SAS, and Python
- Understanding of CDISC dataset submission requirements and SDTM and ADaM specifications
- Strong vendor management experience
- Experience in neuromuscular, ophthalmology, or a related therapeutic area
- Excellent verbal and written communication skills
- Strong attention to detail and proactive mindset
- Ability to work independently and take ownership of study- and program-level statistical activities and deliverables
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
