Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US. The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec has built a deep internal knowledge base in the treatment of diseases related to neuroscience, pain, oncology, inflammation and metabolic diseases. Leveraging these skills and expertise the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery alliances with pharmaceutical and biotechnology companies.We are looking for a highly motivated and passionate, digital forward thinkingSENIOR BIOSTATISTICIANRegulatory / ComplianceAddressing statistical questions from regulatory AuthoritiesWork according to appropriate regulatory standards - GLP & GCPWork following all the updated SOPs, Scientific and Regulatory Guidelines, company PoliciesTechnical / ScientificContribute to the development of Clinical bio-statistical models ensuring the achievement of scientific and quality requirementsLiterature revision of the most updated statistical model and clinical trial design.Interact with internal stakeholders during the clinical trial conductionReview/Write the methodological/statistical sections of Biostatistics deliverables, e.g. Clinical Study Protocols, Statistical Analysis Plan, Clinical Study ReportPerform statistical analyses and quality check of statistical analyses developed by other statisticiansConduct overall statistical review of TFLs for all studies prior to client deliveryReview CRF and other study specific specifications and plansBe updated on the most relevant guidelines pertinent to therapeutic areaReview of randomization specifications and generation of randomization schedulesManagerialInteract with internal stakeholders during the clinical trial conductionReport presentation in meetings and frequent communication with internal project team membersPLEASE APPLY NOW!FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
