Senior Scientist, Biostatistics
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POST DATE 8/9/2016
END DATE 10/9/2016
Merck Sharp & Dohme Corp
North Wales, PA
JOB DESCRIPTIONResponsible for developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics; interacting with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. Specific activities include the following:
• Serve as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
• Develop individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
• Participate in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborate with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Evaluate appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyze data and interprets results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex techniques to these analyses.
• Prepare oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
• Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Is involved in research activities for innovative statistical methods and applications in clinical trial development
Must have an MS in Statistics/Biostatistics or related discipline and 3 years of experience using statistical analysis methodologies and experimental design to support oncology clinical trials and develop novel statistical methodology. Experience must include SAS and/or R. We will also accept a PhD and 1 year of experience.