An experienced Biostatistician with clinical trial setting experience. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
We are seeking a highly motivated Biostatistician to support Vaccines projects across the drug development lifecycle. The ideal candidate will have a strong foundation in statistical methodologies and programming and will play a critical role in analyzing complex manufacturing data to ensure product quality, consistency, and regulatory compliance.
As a Principal Biostatistician, your responsibilities will include:
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
- Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
- Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
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:
Required Qualifications:
- MS or PhD in statistics, biostatistics, or related fields with relevant industry working experience.
- 2+ years experience working in clinical trial setting.
- Proficient with SAS. R is nice to have.
- Have experience in authoring and reviewing SAP/TLF shells.
- Familiar with CDISC standards. Have experience in reviewing SDTM/ADaM specs.
- Have experience in programming and validating SDTM/ADaM/TLFs.
- Experience in submission is a plus
- Experience with Vaccines studies is preferred.
- Strong communication, both verbal and written.
Skills Required
- MS or PhD in statistics, biostatistics, or related field with industry experience
- 2+ years experience working in clinical trial setting
- Proficient with SAS
- R programming experience
- Experience authoring and reviewing SAP and TLF shells
- Familiarity with CDISC standards and reviewing SDTM/ADaM specifications
- Experience programming and validating SDTM/ADaM and TLFs
- Experience with regulatory submissions
- Experience with vaccines studies
- Strong verbal and written communication 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.
-
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.
-
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.
-
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
.jpeg)
