Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Statistician
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Statistician
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Prepare statistical analysis plans/modelling and simulation plans
- Conduct statistical analyses and perform similarity assessment, trending, acceptance criteria assignment
- Design optimization for analytical methods development and process development
- Interpret analyses and write reports
- Propose and apply Design of Experiment approaches for method and process development
- Promote and implement Quality by Design thinking and Design Space methodology
- Provide statistical support in the area of analytical, process development, product development laboratories, stability studies
- Design and host internal database for process and analytical, process & product development, statistical results
- Design databases for trends in monitoring of various processes and analytical data
- Prepare defence of statistical approach for biosimilarity assessment for regulators
What do we expect?
- Experience with SAS
- Knowledge of Design of Experiment
- Knowledge of statistical tools and approaches to validate process
- Knowledge of Bayesian statistics will be a plus
- Knowledge of statistical tools and approaches to validate analytical methods will be a plus
- Knowledge of regulatory demands for statistical analysis of biosimilarity will be a plus
- Excellent analytical skills
- Excellent presentation skills with ability to explain results
- Ability to set priorities and respect tight deadlines
- Great team player with excellent communication skills
- Very good English (written and spoken)
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.