Senior Scientist for Biostatistics

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

We are looking for Senior Scientists, Biostatistics for our Rahway, NJ location to be responsible 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.

* 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.

* Master’s degree in Statistics/Biostatistics or related discipline. * 3 years of experience creating statistical analysis plans and analyzing clinical or preclinical data. Experience must include SAS and/or R. * We will also accept a PhD and expertise in stated areas as demonstrated through internships or experience.