Biostatistician

Beschreibung

• Develop study designs and statistically relevant parts of protocols for PK/PD and confirmatory efficacy and safety studies, including sample size calculation and definition of primary endpoint analyses procedures
• Coordinate and supervise service providers on statistical activities for a clinical study
• Ensure adherence to timelines and adequate quality of all statistical deliverables for the assigned trials
• Develop and review statistical analysis plans (SAPs)
• Foster close collaboration with in-house statistical programming group to ensure high quality deliverables, including tables, listings and figures, SDTMs and ADaMs
• Validate meta datasets (define.xml) for electronic submissions
• Represent biostatistics at Health Authority meetings and write/review statistical contributions to the eCTD for marketing authorization applications to EMA and FDA
• Be responsible for providing answers to EMA & FDA requests
• Provide innovative ideas for designing and analyzing clinical studies and support the set-up of statistically relevant processes and SOPs

• Diploma in statistics or mathematics or related field
• At least 5 years of experience as a biostatistician for clinical trials in the pharmaceutical industry
• Experience in PK/PD studies and international efficacy/safety studies (Phase III)
• Intermediate to expert experience of SAS programming (including SAS macro language) and experience in using NQuery Advisor for sample size calculations
• Ability to coordinate statistical activities for a clinical study
• Experience with CDISC standards
• Good understanding of global clinical trial practices, procedures, and methodologies
• Submission experience and/or history of active interactions with Health Authorities of advantage
• Good team player. Good business ethics