Assoc Prin. Scientist, Biostatistics
Merck - Kenilworth, NJ

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The incumbent is responsible for statistical planning and data analysis of clinical trials. This position requires a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods are applied to designing and analyzing clinical trials in support of worldwide regulatory submissions. This position involves interaction with Medical, Data Management, Merck Research Laboratories Scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical drug projects.

Supervises a statistical or programming staff assigned to a development project as needed. Interaction with contractors and working with the Product Development Teams on outsourced activities as applicable. Reports to Executive Director, Late Development Statistics, Biostatistics & Research Decision Sciences (BARDS).Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under the supervision of management. This includes the following activities: Is involved in early clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions, and carries them out.Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for data analysis.Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.Collaborates with the statistical programming support to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirementsEvaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from experiments to meet objectives of the study protocol.

Independently applies and implements basic and complex techniques to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Merck Management, regulatory agencies, or individual investigators.Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Is responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods and develops new methods and participates in the statistical community.Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings. Presents own research at meetings and seminars. Communicates with statisticians outside Merck concerning technical problems.Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research effort, and other committee works, etc., as needed Qualifications Education Requirements: PhD, MS, or equivalent in statistics/biostatistics Required: 2 years experience for PhD (6 years for MS) in the design and evaluation of clinical trialsSound knowledge of computers and statistical software (e.g., SAS, R).

Excellent communication skillsAbility to function in a team environment. Preferred: Publications in peer reviewed statistical/medical journals are desirable.

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Merck makes medicines for a number of maladies, from stuffy noses and asthma to hypertension and arthritis. The pharmaceutical giant's...