Biostatistik in der klinischen Forschung
Aktualisiert am 05.05.2025
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 01.06.2025
Verfügbar zu: 100%
davon vor Ort: 0%
R
SAS
Python
Good Clinical Practice
German
native
English
experienced

Einsatzorte

Einsatzorte

Berlin (+300km) Hamburg (+300km)
Deutschland, Schweiz, Österreich
nicht möglich

Projekte

Projekte

8 Monate
2022-05 - 2022-12

Safety programming of TLF in Late Development Stage / Phase III-IV

Senior Biostatistician
Senior Biostatistician
  • Safety programming of TLF in Late Development Stage / Phase III-IV
  • Development of Statistical Analysis Plans for pooled multi-center studies
  • Commitment to reports of compound combinations in oncology trials
Cytel
1 Jahr
2021-01 - 2021-12

Data assessment in neurological sleep experiments

Statistician:
Statistician:
  • Data assessment in neurological sleep experiments
  • Adaptive Sleep evaluation by Galerkin-procedure from multivariate signals
  • App Development for Bluetooth-Device Mentalab Explore including automatic report creation
Mentalab GmbH
5 Monate
2020-08 - 2020-12

Creation of Statistical Analysis Plans for phase II pharmacokinetic studies

Biostatistician
Biostatistician
  • Creation of Statistical Analysis Plans for phase II pharmacokinetic studies
  • SAS programming of statistical reports on SDTM datasets
  • Preparation of international client presentations and meetings
  • Responsible biostatistician in a leading expert team on renal and hepatic studies
PRA Health Sciences
1 Jahr 1 Monat
2018-09 - 2019-09

Sample size estimation and counselling in study design of clinical animal and human trials

Biostatistician
Biostatistician
  • Sample size estimation and counselling in study design of clinical animal and human trials
  • Big-Data SQL-Queries for pharmaceutical industry projects (top 5 pharma)
  • Evaluation of > 15 cardio-, rhythmo-, radiologic and heart surgery studies by multiple imputation, propensity score matching, interactive and ML-ready (survival-)regression models
  • Contribution to medical writing of scientific publications
  • Creation of SOP?s, presentations and statistical review for scientific journal EUROPACE
university hospital ?Herzzentrum Leipzig?
1 Jahr 6 Monate
2017-03 - 2018-08

Creation of statistical reports and analysis plans for clinical trials (Phase III and IV)

Statistician
Statistician
  • Creation of statistical reports and analysis plans for clinical trials (Phase III and IV)
  • SQL-Queries of study databases in CDISC standards
  • Preparation of international presentations and meetings
  •  Work by Standard Operating Procedures (SOPs), technical documentation and regular trainings
  • SDTM Mappings in SAS and statistical course programming in Python
  • Heart Rate Variability app development in Shiny for mobile ExG-Recorder of MentaLab GmbH
Creative Clinical Research CRO

Aus- und Weiterbildung

Aus- und Weiterbildung

12 Jahre 3 Monate
2010-10 - 2022-12

Study Mathematics and Biology

B.Sc. Mathematics and B.Sc. Biology, Universität Kassel
B.Sc. Mathematics and B.Sc. Biology
Universität Kassel
  • Rapid Development with MentaLab: Advanced Signal Processing in Sleep EEG
1 Monat
2020-03 - 2020-03

Biosignals Workshop

Kiel
Kiel
1 Monat
2015-10 - 2015-10

Proteomics Workshop

Tübingen
Tübingen

Kompetenzen

Kompetenzen

Top-Skills

R SAS Python Good Clinical Practice

Produkte / Standards / Erfahrungen / Methoden

Visual Studio
Git
qsub
Bash
XML
Mathematica
Linux
Latex
Word
Excel
Powerpoint

Milestones:

  • WES- and RNA-seq sample size estimation, sequence alignment and annotation, statistical differential computation and quality control on public and private NGS Databases, Protein design in Rosetta, genetic algorithms and MCMC via quantum level energy functions
  • Development of interactive machine-learning intelligent survival regression models for personalized medicine in big-data clinical trials for Germanys biggest hospital provider
  • App-Development for Consumer-Health grad mobile device of ECG and EEG records in collaboration with Charité Berlin implementing chaos theory, stochastic process and time-series analysis, dimensionality reduction and advanced visualization


Personality:

  • Problem solving competencies
  • Diversity of ideas
  • Analytical thinking
  • Team- und entrepreneurial spirit 
  • Passion to create


Tech-Stack:

Data Science 

  • R
  • SAS
  • D3.js
  • MatLab
  • PostgreSQL


App Development

  • Python
  • Shiny
  • Java
  • C++


Web Development

  • HTML
  • CSS
  • Wordpress, json


Procedural & Regulatory Knowledge:

  • International Conference on Harmonization (ICH)
    • E3 Structure and Content of Clinical Study Reports
    • E6 Good Clinical Practice: Consolidated Guidance
    • E9 Statistical Principles of Clinical Trials
  • 21 CFR ? Part 11 Electronic Records; Electronic Signatures
  • Clinical Data Interchange Standards Consortium (CDISC)
    • Study Data Tabulation Model (SDTM)
    • Analysis Data Model (ADaM)
    • Define-XML (Case Report Tabulation Data Definition Specification)
  • CDER Common Data Standards Issues Document


Intership:

2015-012 - 2016-08

Customer: Max-Delbrück-Zentrum für molekulare Medizin Berlin-Buch


Tasks:

  • Development of a gene prioritization algorithm for Whole-Exome-Sequencing in Python


2015-10 - 2015-12

Customer: Quantitative Biology Centre Tübingen


Tasks: 

  • Sample Size Estimation Tool for RNA-seq in R for an HPC-Portal



Einsatzorte

Einsatzorte

Berlin (+300km) Hamburg (+300km)
Deutschland, Schweiz, Österreich
nicht möglich

Projekte

Projekte

8 Monate
2022-05 - 2022-12

Safety programming of TLF in Late Development Stage / Phase III-IV

Senior Biostatistician
Senior Biostatistician
  • Safety programming of TLF in Late Development Stage / Phase III-IV
  • Development of Statistical Analysis Plans for pooled multi-center studies
  • Commitment to reports of compound combinations in oncology trials
Cytel
1 Jahr
2021-01 - 2021-12

Data assessment in neurological sleep experiments

Statistician:
Statistician:
  • Data assessment in neurological sleep experiments
  • Adaptive Sleep evaluation by Galerkin-procedure from multivariate signals
  • App Development for Bluetooth-Device Mentalab Explore including automatic report creation
Mentalab GmbH
5 Monate
2020-08 - 2020-12

Creation of Statistical Analysis Plans for phase II pharmacokinetic studies

Biostatistician
Biostatistician
  • Creation of Statistical Analysis Plans for phase II pharmacokinetic studies
  • SAS programming of statistical reports on SDTM datasets
  • Preparation of international client presentations and meetings
  • Responsible biostatistician in a leading expert team on renal and hepatic studies
PRA Health Sciences
1 Jahr 1 Monat
2018-09 - 2019-09

Sample size estimation and counselling in study design of clinical animal and human trials

Biostatistician
Biostatistician
  • Sample size estimation and counselling in study design of clinical animal and human trials
  • Big-Data SQL-Queries for pharmaceutical industry projects (top 5 pharma)
  • Evaluation of > 15 cardio-, rhythmo-, radiologic and heart surgery studies by multiple imputation, propensity score matching, interactive and ML-ready (survival-)regression models
  • Contribution to medical writing of scientific publications
  • Creation of SOP?s, presentations and statistical review for scientific journal EUROPACE
university hospital ?Herzzentrum Leipzig?
1 Jahr 6 Monate
2017-03 - 2018-08

Creation of statistical reports and analysis plans for clinical trials (Phase III and IV)

Statistician
Statistician
  • Creation of statistical reports and analysis plans for clinical trials (Phase III and IV)
  • SQL-Queries of study databases in CDISC standards
  • Preparation of international presentations and meetings
  •  Work by Standard Operating Procedures (SOPs), technical documentation and regular trainings
  • SDTM Mappings in SAS and statistical course programming in Python
  • Heart Rate Variability app development in Shiny for mobile ExG-Recorder of MentaLab GmbH
Creative Clinical Research CRO

Aus- und Weiterbildung

Aus- und Weiterbildung

12 Jahre 3 Monate
2010-10 - 2022-12

Study Mathematics and Biology

B.Sc. Mathematics and B.Sc. Biology, Universität Kassel
B.Sc. Mathematics and B.Sc. Biology
Universität Kassel
  • Rapid Development with MentaLab: Advanced Signal Processing in Sleep EEG
1 Monat
2020-03 - 2020-03

Biosignals Workshop

Kiel
Kiel
1 Monat
2015-10 - 2015-10

Proteomics Workshop

Tübingen
Tübingen

Kompetenzen

Kompetenzen

Top-Skills

R SAS Python Good Clinical Practice

Produkte / Standards / Erfahrungen / Methoden

Visual Studio
Git
qsub
Bash
XML
Mathematica
Linux
Latex
Word
Excel
Powerpoint

Milestones:

  • WES- and RNA-seq sample size estimation, sequence alignment and annotation, statistical differential computation and quality control on public and private NGS Databases, Protein design in Rosetta, genetic algorithms and MCMC via quantum level energy functions
  • Development of interactive machine-learning intelligent survival regression models for personalized medicine in big-data clinical trials for Germanys biggest hospital provider
  • App-Development for Consumer-Health grad mobile device of ECG and EEG records in collaboration with Charité Berlin implementing chaos theory, stochastic process and time-series analysis, dimensionality reduction and advanced visualization


Personality:

  • Problem solving competencies
  • Diversity of ideas
  • Analytical thinking
  • Team- und entrepreneurial spirit 
  • Passion to create


Tech-Stack:

Data Science 

  • R
  • SAS
  • D3.js
  • MatLab
  • PostgreSQL


App Development

  • Python
  • Shiny
  • Java
  • C++


Web Development

  • HTML
  • CSS
  • Wordpress, json


Procedural & Regulatory Knowledge:

  • International Conference on Harmonization (ICH)
    • E3 Structure and Content of Clinical Study Reports
    • E6 Good Clinical Practice: Consolidated Guidance
    • E9 Statistical Principles of Clinical Trials
  • 21 CFR ? Part 11 Electronic Records; Electronic Signatures
  • Clinical Data Interchange Standards Consortium (CDISC)
    • Study Data Tabulation Model (SDTM)
    • Analysis Data Model (ADaM)
    • Define-XML (Case Report Tabulation Data Definition Specification)
  • CDER Common Data Standards Issues Document


Intership:

2015-012 - 2016-08

Customer: Max-Delbrück-Zentrum für molekulare Medizin Berlin-Buch


Tasks:

  • Development of a gene prioritization algorithm for Whole-Exome-Sequencing in Python


2015-10 - 2015-12

Customer: Quantitative Biology Centre Tübingen


Tasks: 

  • Sample Size Estimation Tool for RNA-seq in R for an HPC-Portal



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