Lead statistical strategy and delivery for Phase I-IV clinical trials embedded with a pharmaceutical sponsor. Design analyses, support protocol and reporting activities, oversee programming/CRO work, apply SAS/R (R Shiny)/Python and ML/DL methods for analyses and automation, and mentor junior statisticians.
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 integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
As a Principal Biostatistician, your responsibilities will include:
- Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) 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.
- 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 behaviours
- SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
- Knowledge of R programming (R Shiny/Python)
Cytel Pune, Mahārāshtra, IND Office
Pune, India
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