JOB DESCRIPTION
Who Are You?
An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's Real-World Evidence (RWE) activities. You are motivated 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 Senior 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:
This role is to support our customer's RWE activities. Having exposure to this area is strongly desired, and will enable collaborating effectively, with colleagues from the different functions involved. Strong statistical skills and a flexible, customer-oriented mindset, but in full adherence to good statistical principles, will make you an asset for this role.
RESPONSIBILITIES
* Providing statistical support to our customer's RWE activities
* Provide statistical contributions to design, conduct, analysis planning and evaluation of RWE studies (Observational, Registry and other types of studies)
* Contributing to the concept, planning and delivery of scientific publications
* Might potentially also be in involved in HTA (Health Technology Assessment) dossier related activities
* May be involved in customer's strategic initiatives, review committees, standards and template development etc. related to the RWE space.
* Understand and follow applicable guidelines in different regions.
* Collaborate with internal and external functions (e.g. CROs, programming partners, etc.) to ensure meeting project timelines and goals
* Provide review and/or author SOPs and/or Work Instructions related to statistical practices
QUALIFICATIONS
* Master’s degree in statistics or a related discipline. Ph.D. is desirable.
* 5+ years supporting drug development or RWE in the Pharmaceutical or Biotechnology industry.
* Good SAS and/or R programming skills with application to these fields for generation and QC of deliverables and exploratory activities/modelling
* Solid understanding & implementation of CDISC requirements for regulatory submissions.
* Full commitment to driving effective delivery and contributing to the strategic goals of the customer's project/product teams
* The ability to build strong external & internal relationships.
* Effective communicator: able to explain methodology and consequences of decisions in lay terms.
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