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Senior Biostatistician

Employer
Cytel - USA
Location
United States;Homeworking
Salary
Competitive
Start date
19 Jan 2022
Closing date
17 Feb 2022

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Job Details

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

We are hiring a remote Senior Biostatistician to lead and/or support clinical trials for a major pharma company. This position reports to the Sr. Director, Biostatistics in the FSP Services business unit in Cytel.

Your Impact

This client is dedicated to developing breakthrough therapies for neurodegenerative diseases through their deep commitment to degeneration biology and principles of translational medicine.

We are seeking to recruit an experienced Senior Biostatistician. The candidate will lead/support Biostatistics planning activities and deliverables in support of the core clinical development programs and help shape strategies for clinical development programs. The ideal candidate will guide analytical aspects of a core program entering late stage development, inform study designs, develop and implement novel statistical and computational techniques for analyzing data generated both in house and by external CROs, lead reporting and analysis deliverables, and use a combination of curiosity and statistical acumen to identify and solve interesting problems.

About the role
  • Devise, lead and/or support statistical strategies for clinical development of drug candidates including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
  • Ensure statistical integrity of analysis and reporting deliverables, including guidance on statistical methodology, optimization of study designs, endpoint selection, author/review statistical sections of the protocol, clinical study reports and related documents, oversee timelines and study level tasks pertaining to statistical analysis and reporting.
  • Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed.
  • Consult on methodologies for modeling large scale data (e.g., metabolomics, genetic).
  • Interpret, summarize and present data and statistical considerations to internal project teams, senior management, advisory board meetings and to global health authorities.
  • Collaborate with Clinical Operations to select, oversee, contract, and manage Biostatistics vendors and contract research organizations.
  • Teach Stats basics and/or create standard tools and practices to enable colleagues to visualize and gain insights from their data.
  • Seek out interesting problems and use Statistics to solve them.


What we are looking for:
  • M.Sc. (at least 3 years) or above, in Statistics or Biostatistics with clinical development experience in multiple programs.
  • Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology setting.
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities, as an asset.
  • Strong analytical and problem-solving skills; expert collaboration and communication skills.
  • Experience working with orphan indications highly desired.
  • Strong programming skills in R, Shiny, Markdown; working knowledge of Git and Unix/Linux environments.
  • Preferably familiar with industry data standards, including CDISC, SDTM and ADaM data models.
  • Ability and interest to work cross functionally.
  • Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture.


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 learn and grow your career.

Work with and leverage the best and brightest minds in the industry.

Company

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