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.
Position: Major Tasks
Takes 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 Provides statistical and methodological consultation and contributes to multi-disciplinary and multi-company teams.
Facilitates the overall organization and coordination of statistical activities for important studies and projects Leads virtual teams of statisticians and representatives of other functions Influences decision making processes during oncology drug development by use of appropriate statistical methodology (e.g. simulations, meta- analyses or modeling approaches).
Keeps abreast of regulatory and methodological issues and ensures communication of these in the respective teams. Identifies and implements innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts.
Leads the development and evolution of standard processes for routine assessments in oncology clinical development as well as project specific standards Responds to inquiries from health authorities and other internal or external partners The results of clinical trials provide the basis of government approval of each drug and must be presented so as to conform to strict regulatory (e.g. FDA, EMA) standards.
This entails the design and analysis of 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.
The lead statistician contributes 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.
Also, the lead clinical statistician facilitates risk management decisions within our company through the development and implementation of innovative statistical methodology.
Individual Contributor Team Member Team Leader
• PhD or MSc in Biostatistics, Statistics or Mathematics, or related field
• Excellent interpersonal, leadership and communication skills
• Ability 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
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 45614
Functional Area: Clinical Development & Operations