Who Are You?
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods. In your career you have been taking responsibility for statistical matters both at the trial and the project level, and are willing to use that experience to drive best practices at our FSP client's drug development organization. You are enthusiastic, motivated to do great work and collaborate easily with various functions at the client. 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 safety standards and 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:
You will be part of a small but select team at our client which oversees statistical and technical aspects of safety evaluation in drug development. You will work on standards for evaluating safety, including document templates, process related matters and methodological standards and innovation. It is possible that you will also be directly involved in project safety matters.
As a Principal Biostatistician for Safety Standards, your responsibilities will include:
* Drive or contribute to the client's safety standards, e.g. with respect to e.g. developing templates for planning and reporting, operational standards, providing input with respect to technologies, applications, standard reporting tools, processes etc..
* May participate in statistical innovation initiatives with respect to evaluation and reporting safety, including new methodologies and technologies, visualization etc.
* Works with various stakeholders in different functions; participates in and potentially leads cross-functional workstreams and initiatives.
* May interact directly with specific project teams in order to help improve their planning and reporting with respect to safety.
* Project manage own tasks and works with allied team members; plans proactively, anticipates and actively manages change, sets stakeholder expectations as required Independently identifies research articles and reproduce/apply methodology to business problems
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:
* Master’s degree in statistics or a closely related discipline. Ph.D. is desirable.
* 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
* Experience with key safety related activities in drug development, including regulatory submission/ISS, periodic safety reporting, Data Monitoring Committees, Health Authority interactions etc. Strong awareness of regulatory guidelines including ICH and GCP, and experience with CDISC standards.
* Strong methodological skills and an innovation mindset are desirable, as is experience with novel approaches to evaluating safety.
* 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
* Knowledge of SAS is expected; Knowledge of R programming, Python and other tools are strongly desired.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
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