Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Lead Statistician (Associate Director)/Medical Statistics
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Lead Medical Statistician, are to:
- Take the statistical lead for one or more oncology clinical development projects in the role of project statistician, thus facilitating the overall organization and coordination of all statistical activities regarding the oncology clinical development of the projects;
- Provide statistical and methodological consultation and contribute to multi-disciplinary and multi-company teams;
- Facilitate the overall organization and coordination of statistical activities for important studies and projects;
- Lead virtual teams of statisticians and representatives of other functions;
- Influence decision making processes during oncology drug development by use of appropriate statistical methodology (e.g. simulations, metanalyses or modeling approaches);
- Keep abreast of regulatory and methodological issues and ensure communication of these in the respective teams;
- Identify and implement innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts;
- Lead the development and evolution of standard processes for routine assessments in oncology clinical development as well as project specific standards;
- Respond to inquiries from health authorities and other internal or external partners;
- Ensure that the results of clinical trials provide the basis of government approval of each drug and that are presented to conform to strict regulatory (e.g. Food and Drug Administration (FDA), EMA) standards;
- Design and analyze clinical trials and the writing of statistical reports to be submitted to authorities as a crucial part of our New Drug Application (NDA) for each product Statistics and statistical methodology are thus integral parts of drug development and life-cycle management in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance;
- Contribute to drug research, the development of new drugs, the approval of new drugs by health and reimbursement authorities and the life-cycle management of marketed drugs according to the major tasks and responsibilities of the position;
- Facilitate risk management decisions within our company through the development and implementation of innovative statistical methodology.
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 of Science or Ph.D. in Biostatistics, Statistics or Mathematics or related field;
- Excellent interpersonal, leadership and communication skills;
- Be able to work independently as well as collaboratively, as required;
- Excellent knowledge of statistical programming languages (including SAS and R);
- Fluent English skills;
- At least four years as a statistician with significant time spend in pharma, biotech or similar sector;
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations;
- Experience in leading teams of statisticians and/or representatives from other functions;
- High level of expertise in multiple fields relevant for clinical Development.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
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.
State: West Virginia
Location: Residence Based
Reference Code: 363674
Functional Area: General Administration & Corporate Services
Entry Level : Professional