Lead Biostatistician, Early and Exploratory Clinical Statistics
Location:
Rockville , Maryland
Posted:
October 19, 2017
Reference:
WD136906
Basic qualifications:
•Masters in statistics, mathematics, epidemiolog
•At least 5-year experience in pharmaceutical industry
• Has been previously responsible for studies with different designs (dose range, superiority/non inferiority, futility rule,..)
•Experience in SAS software and sample size computation for standard designs

Preferred qualifications:
•PhD in statistics, mathematics, epidemiology
•Ability to work in multidisciplinary team (e.g., give guidance to non-statisticians, provide feedback, engage), some being remotely located
•Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood

Details:
•Provide strategic & statistical input in defining Clinical Development Plans
•Within the context of biologicals product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices (GCP, GSP, ICH, ...).
•Close collaboration with R&D for the validation of assays, Safety for the safety review of our products and with Regulatory for the submission of new products.
•Spreads good statistical practices.
•Drive (search and/or develop) and Implement new statistical approaches, innovation in the business

Key Responsibilities
•Accountable for statistical expertise in bringing vaccines from early/late development to registration:
•Leader in providing innovative approaches to better design and analyse our trials and speed time-to-market
•Provide strong arguments to support upper management decisions. Defend independently statistical positions in external meetings (IND, advisory board) and towards Health Authorities
•Provide active statistical expertise to other department for solving emerging questions requiring specific and complex statistical expertise.
•Coordinate statistical activities related to the Franchise. Responsible for the statistical quality & delivery within the Franchise.
•Ensure consistency across the different product developments in the Franchise and across Franchise.
•Communicate highly technical issues to non-statisticians at senior management level
•Create external network to develop and bring adequate statistical approaches in clinical developments, lead or contributor author on statistical/product development papers, develop collaboration with external experts to efficiently meet the Franchise objectives.
•Lead the deployment (development, build acceptance through external credits from experts or Authorities, implementation) of new methodologies within GSK Bio. May lead the development of new processes/tools.
•Influences new or reviewed Authorities guidelines in statistical approaches for products development.
•Pro-actively support the development of biostatisticians within the organization

*LI-GSK

Contact information:

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