(Senior) Biostatistician (m/f/d)

60306, Frankfurt am Main
30.04.2021

Daten dieser Anzeige

Job-ID: 021503634
(Senior) Biostatistician (m/f/d)

Merz Aesthetics

Germany

https://merzpharma-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.jobinfo&jobid=1016&company_id=30120&version=1&source=ONLINE&jobOwner=992452&aid=1&utm_campaign=jobware&utm_source=jobware&utm_medium=jobware

You provide statistical input to clinical development programs and clinical trials / investigations, including Clinical Development Plans, CTDs, etc. You define statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section You review and provide input to Clinical Trial Protocols, Clinical Study Reports, etc. You deliver input to data collection instruments (e.g. CRF, diary), data management and data validation processes (e.g. data validation checks), definiton of risk-based monitoring procedures (e.g. signal detection process) and other aspects of data collection and validation You specify, coordinate or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS). You define randomization process details; initiate, coordinate and conduct unblinding process You oversee statistical activities outsourced to CRO You coordinate and discuss all statistical aspects in interaction with regulatory bodies such as Scientific Advice Meetings You review and provide input to scientific publications and present study results You interact with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.) You optimize and update biostatistics processes to reflect possible changes in regulatory and organizational requirements

Our leading position in the global market in the areas of Aesthetics, Therapeutics, and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer oriented work and are willing to take up the task of continuing to write our success story? Then join Merz Aesthetics, a division of Merz Pharmaceuticals GmbH, as  (Senior) Biostatistician (m/f/d)  Biometrics Aesthetics THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU: You provide statistical input to clinical development programs and clinical trials / investigations, including Clinical Development Plans, CTDs, etc.  You define statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section You review and provide input to Clinical Trial Protocols, Clinical Study Reports, etc. You deliver input to data collection instruments (e.g. CRF, diary), data management and data validation processes (e.g. data validation checks), definiton of risk-based monitoring procedures (e.g. signal detection process) and other aspects of data collection and validation You specify, coordinate or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS).  You define randomization process details; initiate, coordinate and conduct unblinding process You oversee statistical activities outsourced to CRO You coordinate and discuss all statistical aspects in interaction with regulatory bodies such as Scientific Advice Meetings You review and provide input to scientific publications and present study results You interact with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.) You optimize and update biostatistics processes to reflect possible changes in regulatory and organizational requirements WHAT WE EXPECT FROM YOU:  Graduate studies in Statistics, Mathematics, Natural Sciences or similar At least 3 years experience in Biostatistics Business fluent in English (written and spoken) Familiarity with ICH, GCP, FDA guidelines Experience with EDC systems and SAS, ideally experience with CDISC data standards Strategic and analytical thinking Excellent communicating and team player skills High sense of responsibility and quality awarenessess   Analytical and highly structured way of working WHAT YOU CAN EXPECT FROM US: Meaningful work and exciting projects from day one Collaboration in multi-functional and global teams Flexible work hours Attractive conditions and extensive social benefits Personal & professional development An open & international work environment in a global family-owned business Participation in the company programme "We care for your beauty"   >> Hier bewerben   Then take the next step towards the future with a top employer in the heart of Frankfurt who will offer you freedom to make your own decisions right from the start. We look forward to receiving your online application including your salary expectation, your earliest start date, and the code 1016-120. For more information, visit us at www.merz.de.

Pharma, Chemie, Med.-/ Biotechnologie

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

60306

Frankfurt am Main