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Job #02531

About our client Our client is creating a fully integrated company in the biotechnology field focusing on the development and commercialization of a new technology. Their surfactant replacement therapies have prospective applications across the respiratory field. The company’s new technology is the base for its manufactured goods platform. Planning to use therapies to treat respiratory diseases, the company initially wants to target premature infants. Position Location Senior Director, Biostatistics and Data Management Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide strategic input for clinical/non-clinical/commercial development 2) Interact regularly with senior management and executives in strategy meetings 3) Provide direction and oversee the Biometrics and Data Management Departments for the client 4) Contribute to strategic planning to ensure statistically optimized clinical development plans 5) Assist in creating strategic objectives for regulatory filings 6) Supervise and guide data management and bio-statistics/programming activities for all clinical studies 7) Review, provide input and approve joint statistical/clinical report, integrated summary of safety/efficacy and regulatory related documents 8) Communicate and resolve all statistical related issues with FDA Requirements 1) Ph. D in Statistics/Bio-Statistics from an accredited institution preferred (or equivalent work experience) 2) Minimum 10 years of biotech/pharmaceutical industry experience 3) Neonatology and pulmonology or critical care experience preferred