Miejsce pracy: Niemcy, NORDRHEIN-WESTFALEN
Rodzaj umowy o pracę: na czas nieokreślony, pełny etat
Wymagane wykształcenie: żadne specyficzne
Oferowana płaca: Nie podano
Liczba miejsc: 1
branża
Specjaliści nauk fizycznych, matematycznych i technicznych
Matematycy, statystycy i pokrewni
Statystycy
ZAKRES PRACY:
For a highly respected biopharmaceutical company we are currently recruiting an experienced Senior Biostatistician (m/f) Job-ID: 449 Location: North Rhine-Westphalia Your responsibilities: - Acts as a Clinical Trial Biostatistician (m/f) for several clinical studies within a clinical program or across multiple clinical programs. - Works very closely with the other biostatisticians - Participates in the protocol summary development. Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. - Performs the sample size calculations. Participates in protocol development. Reviews and approves the protocol prepared by the assigned Strategic Partner or other CRO. - Responds to the request for the randomization schedule and serves as randomization specialist when randomization schedule is generated internally. - Interacts appropriately with the IXRS vendor. - Reviews data management related documents. Evaluates the quality of the database. - Authors the Statistical Analysis Plan (SAP) or reviews and approves the SAP if prepared by a Strategic Partner or other CRO biostatistician. - Coordinates with other internal or external biostatisticians and statistical programmers to prepare the statistical analyses. Communicates and coordinates all statistical activities with Strategic Partner or other CRO biostatisticians. - Participates in data review/evaluation meetings. - Reviews the clinical study report and provides input on interpretation of results. - Ensures implementation of the program and GSS standards. - Attends study team meetings and collaborates with the team to meet timelines. - Guides and supports internal and external biostatisticians assigned to support the clinical studies. Acts as a resource for junior biostatisticians on the team. - Understands the regulatory requirements related to design and analysis of studies. - Assists with the statistical deliverables for regulatory submissions and the lifecycle of a development compound. - Contributes and reviews abstracts, posters, presentations and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents. - Senior Biostatistician (m/f) with sufficient experience may act as CPStat as agreed by the Global Statistical Sciences Leadership Team (GSSLT). - Adheres to the company SOPs and working procedures. Your qualifications: - Relevant Master
- s degree. - A minimum of 5
- 7 years in biostatistics within the biotechnology and/or pharmaceutical industry (including CROs). - Experience in all phases of clinical studies, with particular experience in Phase II
- III. - Early stage experience is a plus. - Sound knowledge of the ICH guidelines. - Understanding of the regulatory requirements from EU, US and Japanese health authorities. - Good knowledge of statistical methodology. - Experience with sample size software. - Good knowledge in clinical study related SAS programming. - Fluent English. - Able to communicate clear, precise and accurate. - Able to propose and defend alternative study designs and statistical analyses. - Shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related programs. - Able to work in a multicultural global environment. - Able to adapt to changing priorities and deliver results in a timely manner. Interested? Please mail your CV to kontakt@glaser-personalberatung.de. You are also welcome to contact us at +49 (0) 59 31 - 4 09 99-61. - Geforderte Anlagen: Lebenslauf, Zeugnisse
Czas pracy:
- Bez określenia czasu pracy
Wymagania
source: https://www.ec.europa.eu/eures
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