SRG is seeking a Lead Statistician that ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management of products according to applicable global and regional standards, procedures and regulatory guidelines.
POSITION DUTIES & RESPONSIBILITIES
- Takes the statistical lead for a project in the represented statistics sub-function, for example, in the role of a project statistician.
- Contributes to the development and evolution of project standards.
- Provides statistical and methodological consultation and contributes to multi-disciplinary teams within or across companies.
- Responds to inquiries from health authorities and other internal or external partners.
- Keeps abreast of regulatory and methodological issues and ensures implementation of these in the respective teams.
- Influences decision making processes during drug development and/or life-cycle management by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modeling approaches).
- Develops and implements innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts
- MS in Biostatistics, Statistics or Mathematics
- At least four years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and/or life-cycle management and associated documents and regulations.
- Experience in leading teams
- Experience in multiple fields relevant for his/her statistics sub-function
- Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively
- Good knowledge of statistical programming languages (including SAS and / or R)
- Fluency in English
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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