Dear Allstat
SRG Clinical is pleased to offer to the market a role within Biostatistics with a clinical trials organisation in Switzerland. Due to their continued success and an extremely healthy pipeline they are seeking a Principal Statistician on a permanent basis. If you wish to find out more about the nature of this exciting role please send your CV to [log in to unmask] or call Helena on +44 207 562 1792 or +44 7825 362548.
Principal Statistician
Reporting into the Associate Director, Biostatistics your role will actively provide statistical support to the Clinical R&D Department where your responsibilities will include:
· Providing statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators.
· Preparing statistical analysis plans including table shells.
· Analysing and report results of clinical trials. Provide ad hoc/data driven analyses.
· Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
· Contribute to Clinical Development Plan.
· Serve as statistical lead on NDAs or sNDAs.
You will also work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups as well as providing statistical input to senior management and managing outside CROs and consultants as needed.
Experience and Qualifications:
§ Ph.D. in statistics with a focus on statistical methods appropriate for clinical trials coupled with significant industry experience.
§ Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.
§ Demonstrated skill in the planning, analysis and reporting of clinical trials.
§ Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.
§ Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.
You must be eligible to work in the EEA and posses excellent written and oral English skills. I look forward to your application.
best wishes
Helena
Helena Newman-Mitchell
Biometrics Lead
Direct: +44 (0) 207 562 1792
Fax: +44 (0) 207 562 1799
Mobile: +44 (0) 782 536 2548
Email: [log in to unmask]
Website: www.srgclinical.com <http://www.srgclinical.com/>
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