Scientist I, Clinical Trial Programming

Location: Ridgefield, CT 06877 Status: Full Time Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager) Our CultureAt Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do. Scientist I, Clinical Trial Programming Duties and Responsibilities: Utilizes BI SOPs and guidelines, trial protocols to conduct pharmacokinetic analysis and data quality check. Produce well documented validated programs or trial specific programs to generate pharmacokinetic results listings in clinical trial report (CTR). Perform quality check on the programs and report output to ensure the integrity, accuracy and completeness of the data in clinical reporting. Assist project clinical pharmacokinecist on data structure design to ensure the reporting process is in compliance of protocol.  Provide support for the electronic submission to regulatory agencies worldwide.  Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficacy of future clinical trials.. Obtain technical competence in non-compartmental analysis on clinical pharmacokinetics and pharmacodynamics to increase productivity or effectiveness in the standard clinical trial reporting. Under close supervision, provide estimation of timeline required for the CTR outputs so that a good planning for submission can be performed.Requirements: Bachelors of Science degree in Computer Science or Math with a concentration in Bio/Statistics and the life sciences. A minimum one year of clinical trial programming experience and the knowledge of clinical research are preferred but not required.   Basic knowledge of Biology. Large data set processing, SAS computer programming and elementary statistics. Good organizational skills, problem-solving abilities, time management skills and initiative. Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team. Good written and oral communications skills in the English language. Must be precise, detail oriented, and able to detect subtle inconsistencies in the data simultaneously. Must be able to work independently as well as part of a team.   Corporate Site