Successfully completed various Biostatistics projects
More than 10 years of experience as Biostatistician in clinical trials
Expert in SAS Programming
Longstanding experience in the pharmaceutical and CRO industry
Has already been successfully placed via K-Recruiting
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- University, Applied Statistics, Ph.D.; Statistics, Master of Science
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Senior Biostatistician, Biometrics, CRO Oversight, Statistical Analysis Plans, SAS Programming, Clinical Trials Phase I-IV, Clinical Data Analysis, Oncology, Pharma
Key-Facts
Extract from previous activities
Clinical Research Organization, Germany
Principal Biostatistician
Statistical support and lead to all aspects to their client program for one of the compounds related project (3 individual studies, incl. Oncology)
Developing study synopsis, protocol, and statistical analysis plans (SAP)
Providing daily statistical support for project/study requirements
Reviewing documents for final submissions and addressing regulatory queries from health authorities
Overseeing the CROs outsourced work
Pharmaceutical Company, Germany
Interim Lead Biostatistician & SAS Programmer
Consultation and advice in all aspects of statistical and SAS programming
Working in all phases of clinical trials, focusing on Generic, Metabolism, and Oncology
Involved in observational studies phase IV and III submission studies
Reviewing CDISC standards and developing SDTM and ADaM specifications
Leading statistical programming projects, setting priorities and timelines, and conducting team meetings for operations and stakeholder deliveries
Clinical Research Organization, Germany (via K-Recruiting)
Senior Biostatistician
Develop objectives, design sampling, randomization, & statistical analysis plans to achieve study objectives
Perform appropriate methodologic procedures for statistical analysis
Collaborate with data managers and investigators to align statistical analysis plan with data collection procedures and forms
Perform sample size and power calculations, generates randomization schema, and prepares statistical sections for research protocols and manuscripts