Beschreibung
For a global pharmaceutical company we are looking for a Biostatistician.Conditions:
o as soon as possible
o 6 months with possible Extensiono ECM - employed contractor model
o 5 days on-site
Major Accountabilities:
o 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
o Coordinate and supervise service providers on statistical activities for a clinical study
o Ensure adherence to timelines and adequate quality of all statistical deliverables for the assigned trials o Develop and review statistical analysis plans (SAPs)
o Foster close collaboration with in-house statistical programming group to ensure high quality deliverables, including tables, listings and figures, SDTMs and ADaMs
o Validate meta datasets (define.xml) for electronic submissions o Represent biostatistics at Health Authority meetings and write/review statistical contributions to the eCTD for marketing authorization applications to EMA and FDA
o Be responsible for providing answers to EMA & FDA requests
o Provide innovative ideas for designing and analyzing clinical studies and support the set-up of statistically relevant processes and SOPs
Background:
o Diploma in statistics or mathematics or related field
o At least 5 years of experience as a biostatistician for clinical trials in the pharmaceutical industry
o Experience in PK/PD studies and international efficacy/safety studies (Phase III)
o Intermediate to expert experience of SAS programming (including SAS macro language) and experience in using NQuery Advisor for sample size calculations
o Ability to coordinate statistical activities for a clinical study o Experience with CDISC standards
o Good understanding of global clinical trial practices, procedures, and methodologies o Submission experience and/or history of active interactions with Health Authorities of advantage
o Good team player. Good business ethics o Very good English (oral and written), German of advantage
If you are interested do not hesitate to contact me!
Kind regards
Marcel Otto
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