Principal Biomarker Biostatistician

Assume responsibility for cross-functional discussions in clinical development phases starting from M0/M1 with regard to Translational Medicine/Biomarker activities. Provide high quality input regarding TM/Biomarker aspects into the design of the clinical study (including protocol development) and/or clinical development plan (CDP), the setup of the study to make sure biomarker data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.

Use of artificial intelligence and machine learning approaches (e.g. classification, clustering, artificial neural networks, deep learning) on clinical data sets (biomarker profiles, genome-wide datasets, medical imaging data, continuous data from wearable devices). Accountable for all statistical deliverables related to the study regarding TM/Biomarker aspects, e.g. Biomarker Statistical Analysis Plan and statistical appendices (TLGs and in-text tables).

Create productive work environment. Coordinate the activities of external partners and CROs for biomarker data generation or biomarker statistical activities. Perform pre-processing and normalization of biomarker data. Perform and/or coordinate with the programming team the production of the definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of biomarker statistical analyses. Review and examine statistical data distributions/properties.

Oversee execution of the statistical analyses according to the Biomarker SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs. Propose, prepare and perform exploratory biomarker data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency, Disclosure and internal data sharing. Provide technical guidance to junior staff.

Plan and track study/project activities and timelines. Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation. Represent statistics to participate in scientific or technology working groups or cross function initiatives; contribute to operation process optimization and provide inputs to biomarker statistics standards.

PhD/MS in statistics or related discipline with min of 3 years of pharmaceutical experience. Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience. Broad knowledge and good understanding of advanced statistical concepts and techniques, in particular high-dimensional statistics. Able to work in departmental computing environment, do advanced statistical analyses using R and possibly other languages (python, C++). Demonstrated strong interpersonal and communication skills.