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Irfa******
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Germany
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Last Update: 03.05.2019 at 12:00
Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Mannheim Area, Germany
Country
Germany
Category
Healthcare
Description
Main responsibilities for the Prinicpal Biostatistician role include: • Serves as the Lead Biostatistician on programs of studies or submissions, or on simple to complex individual studies. • Serves as an independent reporting statistician on data monitoring committees. • Develops statistical analysis plans and reporting specifications for simple to complex clinical studies. • Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies. • Performs senior review of TFLs and statistical analysis plans. • Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists. • Performs lead review of TFLs and derived datasets for clinical studies. • Contributes to clinical study protocols and clinical study reports. • Reviews simple to complex randomization specifications and dummy randomization schemes. • Trains and mentors new or junior statisticians on statistical methods and PRA procedures. • Provides statistical training at monthly seminars. • Provides statistical consultancy to our clients. • Serves as a technical expert and presents at scientific conferences. • Participates in bid defense meetings. • Represents our clients regarding statistical issues at regulatory meetings. You are: MSc qualified Statistician, project delivery focused and have excellent communication skills Here at PRA we want our employees to succeed and ensure that they are set up for this success through continued training, development and support. To be successful in this position you will have:
- MSc or PhD in Medical Statistics or Biostatistics with demonstrated expertise in multiple statistical areas.
- You will have extensive statistical experience working within a CRO and or the pharmaceutical industry.
- The ability to contribute your statistical expertise to the design, analysis and reporting of global clinical studies.
- The ability to plan, supervise, implement and monitor the statistical process for numerous and complex clinical trials
- Excellent communication skills and experience of successful sponsor interactions in leading projects or programs of studies, business development and consultancy with sponsors.