- Represent statistics in cross-functional project and study teams in multiple projects
- Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
- Perform sample size calculations, develop statistical analysis plans and lead TLF development
- Perform statistical analyses and validate analysis results
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
- Develop, implement and improve statistical processes and standards
- Support and participate in the development of departmental strategies
- Interact with global regulatory authoritiesKey Skills and Requirements:
- PhD or Masters in statistics or biostatistics
- Five years (Master) and three years (PhD) experience in the pharmaceutical industry and/or CRO including submission experience
- Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
- Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
- Preferred experience with clinical study designs in oncology or infectious diseases If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer. #Biometrics
Associate Director Biostatistics - Mainz (), Deutschland - Proclinical
Beschreibung
Associate Director Biostatistics - Permanent - Remote
Proclinical are recruiting for an Associate Director Biostatistics to join a global biotech company. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
Responsibilities: