Provide high quality input regarding translational medicine/Biomarker aspects into the design of the clinical study (including protocol development), 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.
Oversee the execution of the statistical analyses for biomarkers according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of biomarker 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.
Perform and/or coordinate with biomarker programmer on the production of biomarker statistical analyses. Review and examine statistical data distributions/properties.
Propose, prepare and perform exploratory biomarker data analyses, ad-hoc analyses as relevant for the study or project objectives. Oversee the study data specifications, the production of the statistical analyses and the quality control coordinating with the biomarker programming team lead.
Plan and track project/study activities and timelines together with the Global Head of Biomarker Statistics group. Contribute to operation process optimization and provide inputs to statistics and quality standards. Define team priorities and goals, conduct performance review and assist in problem solving. Define the development plan and conduct the continuous trainings for junior staffs.
Qualifications
Experience:
7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experiences.
Experience of project/with people management and development preferred.
Soft and technical skills:
Broad knowledge and good understanding of advanced statistical concepts and techniques
Good knowledge in handling complex biomarker data (e.g., RNAseq, scRNAseq, Olink, flow cytometry data etc.)), knowledge in pathway level and network analyses is a plus.
Able to work in departmental computing environment, do advanced statistical analyses using R&R-Shiny and possibly other languages (python, C++, …)
Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences
Demonstrated interpersonal and communication skills and able to work in cross functional and global team setting
Education: MS or PhD degree in Statistics or relevant fields
Languages: Highly effective communication in English, both oral and written.
