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Principal Biostatistician - Gastrointestinal Trials / Simulations / R (Remote, US or Canada)

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Date: Feb 21, 2021

Location: Piscataway, NJ, US Piscataway, NJ, CA Piscataway, NJ, 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.

 

Looking for an invigorating opportunity to leverage your statistical know-how and make an immediate impact, with the opportunity to expand your skills in regulatory submissions, complex innovative/adaptive designs, Bayesian methods, simulations and R programming?  Or how about the next step up in your career as Principal Biostatistician?  Cytel’s growth has been on a consistent up-swing for the past 3 decades and we want YOU to benefit from our success! We have several new openings in our FSP division.
 
As a member of our FSP group, you will be dedicated to one of our major Pharma clients,  working as an extension of their staff to lead and support clinical trials for drug development, with the opportunity to leverage your experience in late-phase trials and regulatory submissions for Gastrointestinal studies.

 

Your Impact
 

  • 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. Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
  • 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.
  • 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. PhD preferred.
  • 5-10 years’ experience in statistical or biostatistical analysis supporting clinical trial operations for drug development in the pharma/biotech industry
  • At least 3 years of recent late-phase trials (II & III) for drug development, including submissions experience required- ISS/ISE.  
  • Experience in simulations required using SAS or R.  R programming experience strong desired.
  • Adaptive Designs experience required, with Bayesian methods strongly desired.
  • Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA required
  • Study Lead experience working with cross-functional teams. Experience leading global teams a plus.
  • Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. 
  • Solid understanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and review of datasets.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
     

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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