Sr Bio Statistician
3- 6yrs exp
PhD (Statistics) (OR) MSc (Statistics)relevant experience in the design, execution, analysis and interpretation of clinical trials.
Expertise in a broad range of statistical methodologies (e.g. Experimental design, mixed models, Bayesian methods, linear and nonlinear regression etc..)
Prior experience with pharmacokinetic and pharmacodynamic (i.e., biomarker) endpoints; and linear as well as nonlinear dose response modelling with application to real problems is a plus
Excellent interpersonal and communication skills; record of building and maintaining strong working relationships; demonstrated ability to explain novel and standard methods, both to fellow statisticians and to scientific and clinical colleagues.
Excellent influencing skills, which are applied effectively at all levels of an organization and across multiple functions.
Strong time management skills; able to effectively organize and manage a variety of tasks across different projects
Self-motivated, independent worker
Preferred qualifications :
A good understanding of drug development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and/or business objectives
Experience in submissions and interacting with regulatory bodies.
Experience providing support for publications (both analyses and review).
Experience of working with, and co-coordinating CROs.
Experience with modeling and simulation, and other innovative methodologies
Proven ability to project manage and prioritize activities.
Key responsibilities:
Considered as an internal and/or external statistical expert in one or more statistical methodologies (e.g. Bayesian and Frequentist etc.)
Provide broader technical knowledge, expertise, support and advice (e.g. statistical methodologies) to own team and other teams
Building and maintaining effective strategic relationships with internal and external partners to meet business needs
Recommending clear strategies for Therapeutic Area projects, process improvement initiatives.
Building credibility and presence with stake holders
Influencing clinical development plans, regulatory and commercial strategies
Acting as a coach, mentor and providing input for development discussions
Identifying, developing and implementing novel statistical methodologies in support of medicines development and product life-cycle management
