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EApps Tech LLC
4208 Six Forks Road, Suite 1000
raliegh, NC, United States
Nashville, TN, United States
Contract - Corp-to-Corp
Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics. The incumbent may initially work in the vaccine therapeutic areas.
This position involves interaction with Clinical, Regulatory, Statistical Programming, Data Management and other client Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
erves 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.
Involves in research activities for innovative statistical methods and applications in clinical trial development
With a Masters, a minimum of (3) years work related experience
Knowledge of statistical analysis methodologies and experimental design. Working knowledge of statistical and data processing software e.g. SAS and/or R.
Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
Ability to learn, be proactive and motivated, and consistently focus on details and execution.
Strong oral and written communication skills
Understanding of the Biology of Disease, as well as Drug Discovery and Development.
Ability to work effectively with personnel with different functional background.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives
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