Your tasks and responsibilities
Bayer U.S. LLC’s Whippany, NJ, office seeks a Statistician
The primary responsibilities of this role, Statistician, are to:
- collaborate with representatives from other functions to plan and execute relevant experiments/studies/analyses.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- master’s degree (or foreign equivalent) in Statistics, Mathematics, or a related field
- two (2) years of experience in a related position
- project management within statistical programming global function;
- leading resources or a global team;
- several different TAs, especially in Cardio Vascular;
- leading the effort to continuously improve processes to conform to evolving industry standards and participating in the ongoing review and development of quality systems and processes, including CDISC implementation (SDTM and ADaM mapping);
- supporting HAQ from U.S. FDA and/or other health authorities globally, including EMA, PMDA, CFDA etc. as well as preparing responses to agency questions and negotiating with other functions regarding deliverables and timelines;
- working with SAS and Base SAS, SAS/STAT, SAS Macro language, SAS SQL and R language as well as programming in NDAs with eCTD formatted NDA submissions;
- statistics (such as regression, survival analysis, Bayesian statistics, sample size determination, and statistical simulation);
- relevant regulatory guidelines and standards (e.g., FDA, ICH and EMA);
- prioritizing and managing multiple projects simultaneously; (x) post-marketing trials and medical affairs support; and
- SAS, R, WinBUGs, EAST, and other relevant statistical software.
- able and willing to travel domestically and internationally up to 15%.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.