YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Lead Statistical Analyst, are to: 

• Provide statistical programming and validation support for assigned clinical study/project;
• Contribute to study TLF and ADS specs;
• Ensure the development of programs and use of project standards for all analysis datasets, tables, listings and figures for assigned project with close cooperation with the study/project statistician;
• Lead and oversee all statistical programming function deliverables required for submissions (IND/NDA) to regulatory authorities for assigned projects/studies in compliance with CDISC standards;
• Coordinate activities of assigned statistical programming team members;
• Participate on global teams that evaluate processes and make suggestions for process and system needs and improvements;
• Aid junior and external programmers in the development of statistical programs;
• Work in close cooperation with other Clinical Operations departments;
• Value added to the success of the company: What are the main objectives of the function;
• Contribute to drug research, the development of new drugs, the approval of new drugs by health authorities and the surveillance of marketed drugs according to the major tasks and responsibilities of the position (cf. sec. 3).

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:

Required Qualifications:

• Bachelor of Science in Statistics, Mathematics, Computer Science, Natural Sciences, Informatics or related field or equivalent of theoretical/technical depth or Master of Science Statistics, Mathematics, Computer Science, Natural Sciences, Informatics, or related field or equivalent (of theoretical/technical depth);
• At least three years of experience in statistical programming or statistics in the pharmaceutical or biotechnology industry;
• Have a thorough knowledge of Databases, CDISC standards and be well connected with the industry working groups;
• Hands-on experience with software like R, Shiny, Spotfire or any other similar statistical interactive tool;
• Project management or equivalent experience would be an asset;
• Excellent demonstrated interpersonal, presentation and communication skills.

Preferred Qualifications:

• Experience in SAS;
• Oncology experience.