The Senior Scientist will develop and apply innovative approaches to clinical data analysis, with a focus on proteomics and transcriptomics. This role is pivotal in our efforts within Translational Medicine, striving to harness the power of multi-omics integration to uncover novel biomarkers and pathways that are essential for understanding the response to therapy in rare diseases across a spectrum of therapeutic areas, including Hematology, Nephrology, Neuroscience, Cardiovascular, Metabolic Diseases, and Rare Oncology.
The successful candidate will be instrumental in creating workflows and applying innovative algorithms to analyze clinical multi-omics data. This includes the development of visualization tools tailored for the intricate interpretation of proteomics data, providing comprehensive analytical support for omics study design in close collaboration with clinical, biomarker, and translational groups. A key aspect of this role involves the integration of proteomics data with other omics datasets, synthesizing complex information into actionable insights and clear, concise recommendations for our collaborators.
Contribute to the design and analysis of clinical trials, employing advanced biostatistical methods to ensure the statistical rigor and clinical relevance of our studies. This role also includes contributing to the delivery of Clinical Study Reports (CSRs), regulatory submissions, and the development of standard processes aimed at enhancing the quality, efficiency, and effectiveness of the Clinical Bioinformatics group. Through these efforts, the Senior Scientist will play a crucial role in advancing our understanding of rare diseases and contributing to the development of novel therapeutic strategies.
Accountabilities
Advanced Statistical and Bioinformatics Analysis: Utilize sophisticated statistical techniques, including survival analysis, longitudinal data analysis, mixed-effects models, and machine learning algorithms, to analyze and interpret data from clinical trials and research studies. Design and implement bioinformatics pipelines for the integration and analysis of multi-omics data sets, demonstrating advanced statistical models to derive biological insights.
Clinical Trial Design and Analysis: Spearhead the bioinformatics and biostatistics components of clinical trial design. This includes conducting power analysis, estimating sample sizes, devising randomization strategies, and developing comprehensive statistical analysis plans. Play a pivotal role in interpreting trial results to ascertain their clinical relevance.
Collaboration and Strategy Development: Engage in collaborative research efforts with interdisciplinary teams, ensuring the statistical integrity of study designs and the validity of data interpretations. Offer biostatistical expertise to aid in decision-making and the formulation of research strategies.
Knowledge Dissemination and Regulatory Submissions: Effectively communicate complex statistical concepts and findings to a diverse audience, including scientists, clinicians, and team members, through both publications and presentations. Contribute to the delivery of Clinical Study Reports (CSRs), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases, and Tables, Figures, and Listings (TFL) outputs, adhering to applicable data standards and regulations. Assist in the statistical programming aspects of regulatory submissions, including the specification and delivery of pooled safety/efficacy databases and outputs, as well as responses to regulatory inquiries.
Process Improvement: Actively contribute to the development of standard processes aimed at enhancing the quality, efficiency, and effectiveness of the Clinical Bioinformatics group
Essential Skills/Experience
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