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Principal Biostatistician - Vaccine Trials (Remote, US / Canada)

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Date: Feb 18, 2021

Location: Boston, MA, US Boston, MA, CA Boston, MA, CA

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

The Principal Biostatistician provides 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.

 

Responsibilities include but are not limited to:

  • Lead statistical teams on clinical development projects, 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.
  • 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.

 

Qualifications:

  • Master's in Statistics, Biostatistics or related discipline
  • At least 8 years of experience as Biostatistician in the Pharmaceutical/Biotechnology industry in clinical development with experience as a Lead Biostatistician for clinical development projects.
  • Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data e-submission to FDA
  • Fluent in English (French or German is a plus)
  • Experience with SAS & CDISC
  • Familiar with study design for vaccine immunogenicity trials and vaccine efficacy trial is a plus, but not required.

  • Experienced in vaccine immunogenicity data analysis and efficacy analysis is a plus, but not required.
  • Experience in CDISC data standards and various statistical modelling techniques.
  • Should have very strong statistical skills in statistical aspect of study design, power/sample size calculation, reviewing statistical analysis and simulation.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.


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