ClinicaI Statistics

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ClinicaI Statistics -Senior Statistician 

Position Purpose:

A Senior Statistician independently provides statistical expertise to cross-functional teams, leads teams of statisticians and programmers, and ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management of Bayer products according to applicable global and regional standards, procedures and regulatory guidelines.

Geographical Scope: global

Major tasks and responsibilities:

• Collaborates with representatives from other functions to plan studies, execute analyses and report results, for example in the role of a study statistician or project statistician.

• Leads virtual cross-functional sub-teams within DS&A.

• Implements standard processes for routine analyses.

• Develops the statistical analysis plan for studies (or integrated analyses).

• Facilitates the overall organization and coordination of statistical activities.

• Assumes responsibility for the production and accuracy of the statistical analysis and interpretation of the results.

• Works independently on statistical questions and tasks.

• Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers.

Value added:

• Statistics and statistical methodology is an integral part of drug development and life-cycle management impacting the planning, design, analysis and reporting of studies, projects and programs in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance.

• The Senior 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 (cf. Sec. Major Tasks of Position).

Contribution Context:

Þ Individual Contributor

Þ Team Member 

Þ Team Leader 

Work relations:

• Statisticians and Statistical Analysts

• Study Team Members and/or Clinical Team Members

• External providers (e.g. CRO, Academic groups)

• External collaboration partners

Qualification:

• PhD or MS in Biostatistics, Statistics or Mathematics

• At least two years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector

• Strong communication skills and ability to work both, independently and collaboratively

• Good knowledge of statistical programming languages (including SAS and / or R)

• Fluency in English