The Principal Biostatistician leads clinical studies, provides statistical expertise for trial processes, and collaborates with sponsor teams on HTA submissions.
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:
- Provide statistical input into planning and analysis of Indirect Treatment Comparison (ITC).
- Support Health Technology Assessment (HTA) dossier submission and negotiation.
- Create specifications and perform analyses such as time-to-event and longitudinal analysis.
- When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
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:
- PhD in statistics or Master's degree in statistics or related subject required along with clinical trial experience.
- Relevant experience in statistical or biostatistical analysis supporting HTA activities.
- Understanding of the HTA-related guidelines.
- Excellent verbal and written communications skills.
- Ability to organize multiple work assignments and establish priorities.
- Working SAS & R programming knowledge required.
- CDISC knowledge required.
- Experience in R is preferred.
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Cytel Pune, Mahārāshtra, IND Office
Pune, India
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