PitchMeAI
Cytel

Principal Biostatistician FSP

Cytel · Canada

  • Hybrid
  • Full-time
  • $150,000 / year
  • Canada

Job highlights

  • Lead biostatistics for clinical trials.
  • Collaborate with cross-functional teams.
  • Oversee statistical programming activities.
  • Utilize SAS and R for analysis.
  • Mentor junior statisticians.

About the role

Principal Biostatistician

Who Are You?

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate an integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate processes for reducing effort and time for repeated use.

Responsibilities

  • Lead statistical activities for assigned Clinical Trials (Phases 1 to 2) independently from protocol design to reporting of results.
  • Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
  • Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
  • Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
  • Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
  • Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
  • Oversight of more junior Statisticians as required.

Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

  • Minimum of Bachelor's degree in statistics or a related discipline.
  • 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
  • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviors.
  • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
  • Knowledge of R programming (R Shiny/Python).

Key skills/competency

  • Biostatistics
  • Clinical Trials
  • Statistical Analysis
  • SAS Programming
  • R Programming
  • Protocol Design
  • Data Analysis
  • Pharmaceutical Industry
  • Biotechnology Industry
  • Health Authorities

Skills & topics

  • Principal Biostatistician
  • Biostatistics
  • Clinical Trials
  • Statistical Analysis
  • SAS
  • R Programming
  • Pharmaceutical
  • Biotechnology
  • Protocol Design
  • Data Analysis

How to get hired

  • Tailor your resume: Highlight your 9+ years of clinical trial experience and SAS/R programming skills.
  • Showcase leadership: Emphasize your ability to lead statistical activities and mentor junior staff.
  • Demonstrate industry knowledge: Detail your experience in the pharmaceutical or biotechnology sectors.
  • Prepare for technical questions: Be ready to discuss statistical methods, SAS/R usage, and trial design.
  • Highlight collaboration: Provide examples of working effectively with cross-functional teams and clients.

Technical preparation

Master advanced SAS/R programming techniques.,Practice clinical trial design and analysis.,Review statistical methods for Phases 1-2.,Prepare to discuss machine learning applications.

Behavioral questions

Describe a time you led a team.,How do you handle client collaboration challenges?,Share an example of innovative problem-solving.,How do you ensure quality in your work?

Frequently asked questions

What are the primary responsibilities of a Principal Biostatistician at Cytel?
As a Principal Biostatistician at Cytel, you will lead statistical activities for clinical trials from protocol design to reporting, represent the Statistics function on cross-functional teams, oversee programming activities, and utilize SAS/R for various analyses. You will also mentor junior statisticians and contribute to broader initiatives.
What qualifications are essential for the Principal Biostatistician role at Cytel?
Essential qualifications include a minimum Bachelor's degree in statistics or a related field, 9+ years of experience supporting clinical trials in the pharmaceutical or biotechnology industry, strong SAS programming skills, and knowledge of R programming. Leadership, attention to detail, and excellent communication are also crucial.
Is this a sponsor-dedicated role with Cytel?
Yes, this is a sponsor-dedicated role. You will be working fully embedded within one of Cytel's global pharmaceutical clients, offering a unique opportunity to be at the heart of their innovation.
What type of clinical trials will a Principal Biostatistician be involved in?
You will lead statistical activities for assigned Clinical Trials, primarily focusing on Phases 1 to 2, from protocol design through to the reporting of results.
What statistical software is primarily used in this Principal Biostatistician role?
The role primarily utilizes SAS for quality control, critical outputs, efficacy/safety tables, and inferential statistical analyses. Knowledge of R programming (including R Shiny/Python) is also required for various analytical tasks.
Does Cytel offer training and development for Principal Biostatisticians?
Yes, Cytel emphasizes employee success through consistent training, development, and support, enabling individuals to grow and excel in their roles.
Will I be mentoring other statisticians in this Principal Biostatistician position?
Yes, a part of the responsibilities includes the oversight of more junior statisticians as required, providing an opportunity for leadership and mentorship.