Biostatistician with more than 10 years of experience in clinical research.
Aktualisiert am 04.11.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 16.11.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Biostatistician
German
Native
English
Proficient

Einsatzorte

Einsatzorte

Kemnath, Stadt (+75km)
möglich

Projekte

Projekte

3 Jahre 1 Monat
2022-11 - heute

Immuno-oncology Phase I and Phase II studies

Principal Biostatistician
Principal Biostatistician
  • Immuno-oncology Phase I and Phase II studies
  • Lead program- and trial-level statistical and programming related activities.
  • Represent Statistics in cross-functional teams
  • Ensure proper planning, execution, and reporting of clinical trials with regard to endpoints, statistical methodology, sample size, and reporting in accordance with regulatory requirements and good clinical, statistical, and programming practice
  • Oversight of statistical and programming activities outsourced to CROs, review of deliverables
  • Contribution to eCRF design
  • Author SAPs including safety, efficacy, and correlative science
  • Conduct statistical analyses using R and SAS
  • Preparation of outputs and participation in Data Quality Review Meetings, Safety Review Meetings, and Independent Data Monitoring Meetings
  • Contribute to the preparation of publications
Affimed GmbH, Germany, Home Office
3 Jahre 1 Monat
2019-10 - 2022-10

Statistical representative in client meetings

Senior Biostatistician
Senior Biostatistician
  • Lead Biostatistician for early phase studies
  • Statistical representative in client meetings
  • Development of Statistical Analysis Plans (SAPs) and shells
  • Planning of randomization schedules
  • Review of tables, listings, and figures (TLFs)
  • Protocol review and statistical input
Syneos Health, Germany, Home Office
1 Jahr 3 Monate
2018-07 - 2019-09

Statistical support for late-phase clinical studies

Biostatistician
Biostatistician
  • Statistical support for late-phase clinical studies
  • Development of SAPs and Biometric Reports
  • Programming of TLFs using SAS
TFS Trial Form Support GmbH, Home Office
1 Jahr 3 Monate
2017-04 - 2018-06

Responsible for biometric team management

Biostatistician
Biostatistician
  • Lead Statistician for Phase II and III studies
  • Responsible for biometric team management
  • Organized and led Data Evaluation Meetings
  • Acted as biostatistics contact in client interactions
  • Contributed to safety signal detection and data cleaning meetings
  • Oversaw budget planning and time/resource management
  • Worked with ADaM and SDTM datasets
  • Ensured compliance with GCP and ICH guidelines
Chiltern International GmbH, Home Office
5 Jahre
2012-05 - 2017-04

Programmed and reviewed TLFs

Consultant for Biostatistics
Consultant for Biostatistics
  • Study Statistician for Phase I trials and biomarker projects
  • Developed statistical analysis plans and conducted statistical analyses
  • Programmed and reviewed TLFs
  • Provided statistical input for clinical study reports
  • Modeled high-dimensional data and conducted exploratory data analyses
Chrestos Concept GmbH & Co.KG, Essen, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Jahr
2011-07 - 2012-06

Data Science

Master of Science, Final Grade: 1.5, Faculty of Statistics, TU Dortmund
Master of Science, Final Grade: 1.5
Faculty of Statistics, TU Dortmund
5 Jahre 10 Monate
2005-10 - 2011-07

Data Analysis and Data Management

Bachelor of Science, Final Grade: 1.9, Faculty of Statistics, TU Dortmund
Bachelor of Science, Final Grade: 1.9
Faculty of Statistics, TU Dortmund

Kompetenzen

Kompetenzen

Top-Skills

Biostatistician

Produkte / Standards / Erfahrungen / Methoden

Profile Summary

Biostatistician with more than 10 years of experience in clinical research, currently focusing on immuno-oncology Phase I and II trials. Experienced in leading statistical activities at program and study level, including oversight of CRO deliverables and collaboration with cross-functional teams. Previous experience covers multiple therapeutic areas and includes study-level statistical responsibilities, biomarker analyses, participation in DMC and safety review meetings, and contributions to scientific publications. Proficient in SAS and R with a strong background in biometry and data science.

Programmiersprachen

R
SAS
Spotfire

Einsatzorte

Einsatzorte

Kemnath, Stadt (+75km)
möglich

Projekte

Projekte

3 Jahre 1 Monat
2022-11 - heute

Immuno-oncology Phase I and Phase II studies

Principal Biostatistician
Principal Biostatistician
  • Immuno-oncology Phase I and Phase II studies
  • Lead program- and trial-level statistical and programming related activities.
  • Represent Statistics in cross-functional teams
  • Ensure proper planning, execution, and reporting of clinical trials with regard to endpoints, statistical methodology, sample size, and reporting in accordance with regulatory requirements and good clinical, statistical, and programming practice
  • Oversight of statistical and programming activities outsourced to CROs, review of deliverables
  • Contribution to eCRF design
  • Author SAPs including safety, efficacy, and correlative science
  • Conduct statistical analyses using R and SAS
  • Preparation of outputs and participation in Data Quality Review Meetings, Safety Review Meetings, and Independent Data Monitoring Meetings
  • Contribute to the preparation of publications
Affimed GmbH, Germany, Home Office
3 Jahre 1 Monat
2019-10 - 2022-10

Statistical representative in client meetings

Senior Biostatistician
Senior Biostatistician
  • Lead Biostatistician for early phase studies
  • Statistical representative in client meetings
  • Development of Statistical Analysis Plans (SAPs) and shells
  • Planning of randomization schedules
  • Review of tables, listings, and figures (TLFs)
  • Protocol review and statistical input
Syneos Health, Germany, Home Office
1 Jahr 3 Monate
2018-07 - 2019-09

Statistical support for late-phase clinical studies

Biostatistician
Biostatistician
  • Statistical support for late-phase clinical studies
  • Development of SAPs and Biometric Reports
  • Programming of TLFs using SAS
TFS Trial Form Support GmbH, Home Office
1 Jahr 3 Monate
2017-04 - 2018-06

Responsible for biometric team management

Biostatistician
Biostatistician
  • Lead Statistician for Phase II and III studies
  • Responsible for biometric team management
  • Organized and led Data Evaluation Meetings
  • Acted as biostatistics contact in client interactions
  • Contributed to safety signal detection and data cleaning meetings
  • Oversaw budget planning and time/resource management
  • Worked with ADaM and SDTM datasets
  • Ensured compliance with GCP and ICH guidelines
Chiltern International GmbH, Home Office
5 Jahre
2012-05 - 2017-04

Programmed and reviewed TLFs

Consultant for Biostatistics
Consultant for Biostatistics
  • Study Statistician for Phase I trials and biomarker projects
  • Developed statistical analysis plans and conducted statistical analyses
  • Programmed and reviewed TLFs
  • Provided statistical input for clinical study reports
  • Modeled high-dimensional data and conducted exploratory data analyses
Chrestos Concept GmbH & Co.KG, Essen, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Jahr
2011-07 - 2012-06

Data Science

Master of Science, Final Grade: 1.5, Faculty of Statistics, TU Dortmund
Master of Science, Final Grade: 1.5
Faculty of Statistics, TU Dortmund
5 Jahre 10 Monate
2005-10 - 2011-07

Data Analysis and Data Management

Bachelor of Science, Final Grade: 1.9, Faculty of Statistics, TU Dortmund
Bachelor of Science, Final Grade: 1.9
Faculty of Statistics, TU Dortmund

Kompetenzen

Kompetenzen

Top-Skills

Biostatistician

Produkte / Standards / Erfahrungen / Methoden

Profile Summary

Biostatistician with more than 10 years of experience in clinical research, currently focusing on immuno-oncology Phase I and II trials. Experienced in leading statistical activities at program and study level, including oversight of CRO deliverables and collaboration with cross-functional teams. Previous experience covers multiple therapeutic areas and includes study-level statistical responsibilities, biomarker analyses, participation in DMC and safety review meetings, and contributions to scientific publications. Proficient in SAS and R with a strong background in biometry and data science.

Programmiersprachen

R
SAS
Spotfire

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