BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz, München
from USD 198,900 - 298,300 / year
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Statistical leadership for clinical research in orthopedics, arthroscopy, sports medicine, and orthobiologics. Regulatory statistical submissions experience and medical device industry background required. High autonomy in study design and evidence planning.
Requirements
- Master's degree (or equivalent) in Biostatistics, Statistics, or related field; PhD preferred
- High experience in medical device or pharmaceutical industry
- Proven proficiency in statistical programming (R, SAS, Python)
- Experience with regulatory statistical submissions and applicable standards (FDA, MDR, ISO, ICH)
- Experience with medical device clinical research (preferred)
- Experience with additional data sources (registry, real-world data, observational datasets) (strong positive)
- Collaborative mindset and effective work in cross-functional, global teams
- Strong written and verbal communication skills in English and German
Tasks
- Provide statistical leadership to the Arthrex Research team.
- Shape study designs and evidence planning across teams.
- Act as primary statistical authority for Clinical Research.
- Provide expert statistical guidance.
- Design and guide impactful research.
- Define research endpoints and sample sizes.
- Develop research protocols and Statistical Analysis Plans.
- Perform advanced analytics.
- Deliver submission-ready reports.
- Ensure compliance with ICH, FDA, ISO, GCP, MDR.
- Ensure data integrity and quality.
- Collaborate with data management to optimize collection systems.
- Conduct statistical analyses using R, SAS, or Python.
- Apply mixed-model, categorical, Bayesian, and multivariate approaches.
- Translate statistical insights into action.
- Present results in reports, publications, and briefings.
- Explain complex concepts to diverse stakeholders.
- Mentor and guide junior and non-statistical personnel.
- Act as a statistical subject matter expert.
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- R
- SAS
- Python
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Arthrex, Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Statistical leadership for clinical research in orthopedics, arthroscopy, sports medicine, and orthobiologics. Regulatory statistical submissions experience and medical device industry background required. High autonomy in study design and evidence planning.
Requirements
- Master's degree (or equivalent) in Biostatistics, Statistics, or related field; PhD preferred
- High experience in medical device or pharmaceutical industry
- Proven proficiency in statistical programming (R, SAS, Python)
- Experience with regulatory statistical submissions and applicable standards (FDA, MDR, ISO, ICH)
- Experience with medical device clinical research (preferred)
- Experience with additional data sources (registry, real-world data, observational datasets) (strong positive)
- Collaborative mindset and effective work in cross-functional, global teams
- Strong written and verbal communication skills in English and German
Tasks
- Provide statistical leadership to the Arthrex Research team.
- Shape study designs and evidence planning across teams.
- Act as primary statistical authority for Clinical Research.
- Provide expert statistical guidance.
- Design and guide impactful research.
- Define research endpoints and sample sizes.
- Develop research protocols and Statistical Analysis Plans.
- Perform advanced analytics.
- Deliver submission-ready reports.
- Ensure compliance with ICH, FDA, ISO, GCP, MDR.
- Ensure data integrity and quality.
- Collaborate with data management to optimize collection systems.
- Conduct statistical analyses using R, SAS, or Python.
- Apply mixed-model, categorical, Bayesian, and multivariate approaches.
- Translate statistical insights into action.
- Present results in reports, publications, and briefings.
- Explain complex concepts to diverse stakeholders.
- Mentor and guide junior and non-statistical personnel.
- Act as a statistical subject matter expert.
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- R
- SAS
- Python
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Arthrex, Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Arthrex, Inc.
Industry
Healthcare
Description
Das Unternehmen gehört zu den weltweit führenden Unternehmen im Bereich Orthopädie, Arthroskopie, Sportmedizin und Orthobiologie.
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