Your tasks and responsibilities
Takes the statistical lead for a specific indications and/or compounds within oncology, assuming the role of project statistician for one or more oncology clinical development 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 and regulatory issues and mentors other statisticians and/or statistical analysts.
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 by use of appropriate statistical methodology (e.g. simulations, meta- analyses or modeling 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 expects 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 development programs and products to internal and external stakeholders. These include regulatory agencies, collaborations/business partners, KOLs, etc.
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 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 clinical 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.
• PhD or MSc in Biostatistics, Statistics or Mathematics, or related field
• 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
• At least eight years as a statistician with significant time spend in pharma, biotech or similar sector
• Thorough knowledge of the pharmaceutical
Location: Reading, Cambridge
Functional Area: [sap_fa_16]
Entry Level: 5
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We look forward to hearing from you!
At Bayer UK we have a well established list of preferred suppliers and there are no plans to review these arrangements at present.
Please Note: Speculative enquires from non preferred suppliers directly to the business are not welcome and will be taken into account when reviewing the preferred supplier arrangements. CV's will only be accepted by following our process - this will be with prior arrangement with the Talent Acquisition Team who will grant access to our recruitment portal. In the event of speculative CV's being sent directly to the business, or the Talent Acquisition Team, agency ownership of the candidate will not be accepted.
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