Senior/Principal Biostatistician - FSP (Remote)

Company: Cytel Software Corporation
Location: Durham
Posted on: August 5, 2022

Job Description:

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 drug development. In this role you will join our FSP department and will for our client, one of the top pharmaceutical companies. As Senior/Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders 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.
  • 5+ 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

Keywords: Cytel Software Corporation, Durham , Senior/Principal Biostatistician - FSP (Remote), Other , Durham, North Carolina