We are now seeking a Senior Study Statistician for Oncopeptides. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally. Oncopeptides develops drugs for the treatment of cancer and is in a very exciting phase of development. As Senior Study Statistician you will be accountable for development of statistical strategies, plans, processes and evaluation across Oncopeptides clinical studies. As Senior Study Statistician you will report to Director of Biostatistics. This is a role for you who want to work at a fast growing and dynamic company that is dedicated to make a big difference for the patient.
– Develop and oversee statistical strategies across Oncopeptides clinical studies
– Actively drive, co-ordinate and follow-up statistical analysis plans (SAP) and activities to ensure high quality in analyses within expected timelines
– Oversight of SAP activities performed by vendors to ensure compliance with the agreed scope of work, study protocols, regulatory requirements and standard operating procedures.
– Oversee and manage processes for risk-based/centralized monitoring, in close collaboration with clinical operations and data management, across Oncopeptides clinical studies
– Provide statistical expertise for regulatory submissions to FDA, EMA or other worldwide regulatory agencies
– Initiate and implement process improvements and standards development
– Active involvement in health authority interactions in close collaboration with regulatory affairs, and other cross-disciplinary projects
– Analyze and interpret data across Oncopeptides clinical studies, and writing up results in various related reports
– University degree in statistics
– At least 5 years’ experience from clinical research in pharmaceutical industry:
– Project Management of data management, SAP and related activities.
– Development of clinical protocols, SAP and related documentation.
– Oversight of vendors for data management and statistics.
– Interpretation of results and writing of clinical study reports and scientific communications.
– Experience from confirmatory/pivotal clinical studies and oncology endpoints.
– Statistical programming in SAS.
– FDA, EMA and ICH guidelines and regulations and CDISC data standards
– Service-minded and solution-oriented personality.
– Good cooperation and communication skills.
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