Principal Biostatistician

Company: Cytel Inc
Location: Portland
Posted on: June 9, 2021

Job Description:

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?  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 Functional Service Provider (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.

This is a Senior Statistician or Principal Statistician role depending on years of experience and applicable knowledge.

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.
• Review and verify key statistical outputs.
• 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 pertaining to multiplicity adjustments, gate keeper procedures, tipping point analysis a plus.
• Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA required

Keywords: Cytel Inc, Portland , Principal Biostatistician, Other , Portland, Maine