Job Description

Responsibilities: Providing statistical input to the design, analysis, reporting and interpretation of clinical studies and contribution to publications Identifying, developing and implementing novel statistical methodologies in support of medicine development Influencing clinical development plans, regulatory and commercial strategies. Building and maintaining effective strategic working relationships with internal and external partners to meet business needs. Providing technical advice, mentoring and training Validating analysis output based on relevant SOPs / Guidance s Keeping up-to-date with current literature and may research new methodologies Managing conflicting demands and priorities. Developing creative solutions and applying to problems Basic qualifications: MSc in a statistical discipline (Statistics, Biostatistics or related). Experience (2 yrs + preferable) in the design, execution, analysis and interpretation of clinical trials. Expertise in a broad range of statistical methodologies. 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. 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 of working with, and co-coordinating CROs. Experience with modeling and simulation, and other innovative methodologies

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