Job Vacancies at Cytel

Your Impact

• Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.

• eSUB/submission

• PK analysis and clinical pharmacology

• Longitudinal data/analysis 

• Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

• 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.

• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.

• Contribute to the development of sourcing strategy for projects.

•  Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

What You Offer

• Master's degree in Statistics, Biostatistics or related discipline

• 5+ experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry

• Experience in late-phase trials required

• Experience in immunology: GI and Derm studies required

• eSUB/submission required

• Experience with longitudinal data/analysis is preferred

• Demonstrated team leadership for direct reporting relationships and leadership influence over indirect reporting relationships

• Working SAS & CDISC knowledge required

• Knowledge of PK/PD desired

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You will contribute by:

• providing statistical support to clinical studies, with a focus on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimer’s, Strokes, etc.);
• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing clinical study reports, including integrated summaries for submissions;
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change

What we’re looking for:

• Master’s degree in statistics or a related discipline. PhD strongly desired.
• 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Knowledge and implementation of advanced statistical methods.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
• Strong knowledge of ICH guidelines.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and QC of datasets.
• Submissions experience
• Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to be flexible when priorities change and deal with ambiguity

What’s in it for you:

• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
• Work with and leverage the best and brightest minds in the industry