Principal Biostatistician

Date: May 13, 2022

Location: US

Company: Cytel Software Corporation

As a Principal Biostatistician position represents a key role in both project teams and within the department that provides significant technical and scientific expertise, for example, in a Functional Lead role on complex projects. You will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders. The Principal Biostatistician is expected to have a thorough understanding of advanced statistical methods, keep up-to-date with innovative statistical approaches (e.g, simulations, adaptive designs, Bayesian statistics) and deliver training and/or mentoring to junior staff in advanced statistical methodologies. 

 

You will contribute by:

  • Provide statistical expertise into clinical trial designs  

  • Serve as functional lead on project teams  

  • Develop and review input for clinical trial activities (trial design, protocol, CRF, SS, SAP, specifications, randomization, DB lock activities, analysis, programming and validation, regulatory submission documents)  

  • Interact and coordinate with client staff  

  • Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor 

  • Coordinate activities of other personnel 

  • Mentor Biostatisticians 

  • Provide technical leadership for Biostatistics Group and lead initiatives 

  • Advanced knowledge of statistical methodology and analytic techniques 

  • SAS programming skills, R programming skills a plus 

  • Extensive knowledge of FDA and ICH regulations and industry applicable standards. 

  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents. 

  • Excellent oral and written communication skills 

 

What we're looking for: 

  • Master’s degree in statistics or a related discipline. PhD strongly desired.
  • 8+ 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