Senior Statisticians (multiple openings) at Boehringer Ingelheim Pharmaceuticals, Inc. in 900 Ridgebury Road, Ridgefield, CT 06877.
Job Duties: Act as statistician and/or work in support of statistician for routine and complex phase I-IV clinical trials and/or on projects with established BI experience.
Write statistical selection of the clinical trial protocol. Review report forms. Specify/review the randomization.
Present critical statistical aspects at investigator meetings. Prepare the trial statistical analysis plan. Supervise the analyses.
Interpret and communicate the results. Participate in the writing of accurate, high quality clinical trial report and of publications thereof. Prepare specifications for data analyses of routine clinical trials by outside vendors and assure compliance with the specifications by reviewing vendors' products.
Provide necessary statistical and programming support needed for data mining and ad-hoc analyses within one or across several trials. Support management in resource planning and tracking for assigned trials. Supervise contract research organizations (CROs) for all statistical tasks with emphasis on analysis related processes, prepare an oversight plan, and assure compliance with the specifications by reviewing the CROs products.
Master's degree (US or foreign equivalent) in Statistics, Mathematics, or related field and three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities, or academic institutions; OR Doctoral degree (US or foreign equivalent) in Statistics, Mathematics, or related field with zero (0) years of experience within the pharmaceutical industry, CROs, regulatory authorities, or academic institutions.
Prior experience during or post-degree must include: Sound knowledge of statistical methodology, design of clinical trials, and on processing clinical trial information; Ability to pro-actively identify data issues and solutions and to interact with internal and external bodies (specialists and non-specialists) on routine statistical/methodological issues at the trial level; Ability to write publications (as joint author) of clinical trials or on relevant statistical topics; Demonstrated ability to analyze routine clinical trial data under the supervision of a more senior statistician; Experience with communication and presentation of statistical information to non-statisticians; and Evidence of strong teamwork.
Work Schedule: 40 hours per week (8:00am to 5:00pm)