Principal Statistician

Position:

Major Tasks:

• Takes the statistical lead for Oncology Medical Affairs activities for specific indications and/or compounds within oncology, working closely with the compound and project statisticians on one or more projects and ensuring appropriate development supporting the respective indication within the department.
• Provides statistical and methodological consultation on special statistical methodology or on complex statistical, scientific, regulatory and health technology assessment issues and mentors other statisticians and/or statistical analysts.
• Drives exploratory analyses on internal and external data bases.
• Facilitates the overall organization and coordination of statistical activities on the level of the indications in addition to the projects for which the incumbent is responsible, also ensuring appropriate prioritization within Medical Writing and Statistics Oncology organization.
• Assembles and leads cross-functional virtual teams Influences decision making processes during oncology drug development and life-cycle management by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modelling approaches).

• Keeps abreast of regulatory and methodological issues, anticipates new needs in the area of responsibility and ensures development of innovative solutions.

• Drives development and implementation of innovative statistical methodology. Coordinates work with academic experts on themes related to the field of responsibility.

• Drives the development and implementation of project, indication specific, and global standards. Represents the function with respect to statistical aspects of oncology life-cycle management programs and products to internal and external stakeholders.

• These include regulatory agencies, reimbursement authorities, collaborations/business partners, KOLs, etc. Value Added 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 principal medical 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.

• The principal Medical Statistician is internally and externally visible and works with (academic) experts to develop and implement innovative statistical methods that facilitate quantitative risk management decisions within our company.

Skills:

• PhD or MSc in Biostatistics, Statistics or Mathematics, or related field

• At least 8 years’ experience as a Statistician with significant time spent in Pharma or similar sector

• Outstanding 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

• Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents & regulations.

• Demonstrated leadership skills in leading teams of Statisticians and / representatives from other functions.

• High level of expertise in multiple fields relevant for medical affairs within Oncology development.