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.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We are looking for Senior Scientists, Biostatistics (multiple openings) 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.
Specific activities include the following:
- Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
- Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
- Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
- Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
- Analyzes data and interprets results from clinical trials 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, 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 planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participates 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
- Masters' degree in Statistics/Biostatistics or related discipline combined with three (3) years experience using statistical analysis methodologies and experimental design to support clinical trials and develop novel statistical methodology -OR- PhD combined with one (1) year or more similar experience.
- Experience must include SAS and/or R
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Visa sponsorship is not available for this position.
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