This role is for a biomarker statistician in the Discovery Genomics and Precision Medicine Statistics group which explicitly supports Precision Medicine (PM) in Early Clinical Development (ECD). The groups' responsibilities encompass all clinical programs in the East Coast Research Units (RUs) including Internal Medicine, Inflammation and Immunology, Rare Disease, and the Center for Therapeutic Innovation (CTI). Biomarker statisticians in this team will work collaboratively across research, technical, and clinical teams to deliver analytical and computational support for high dimensional biomarker data sets informing early clinical trials.
The individual in this role must communicate effectively with PM scientists and clinicians and collaborate with colleagues within a matrix organization. They must leverage technical and scientific information from a variety of sources in order to effectively enable data analysis and the scientific interpretation of analysis results, which in turn will be used to drive program decisions.
Skill sets required for this role include fundamental knowledge of statistical analysis (including linear mixed models, survival analysis, meta-analysis, dose-response modeling, etc.) and design, demonstrated ability to create computational tools for data visualization, familiarity with modern multi-dimensional genomic data technologies, and the ability to execute pathway analyses from the results of these types of data.ROLE RESPONSIBILITIES
- Collaborate with Precision Medicine (PM) scientists and clinicians in the design, analysis, and reporting of multi-dimensional biomarker data in early clinical trials, including assistance with visual summarization and interpretation of results, all done to enable objective decision-making for each clinical program.
- Defines and evolves best practices across the group and partners with Research Unit, Business Technology (BT), and partner line bioinformatics experts to align approaches, develop best practices and assess and develop new technology.
- Responsible for ensuring high-quality data analysis is incorporated into clinical exploratory-research programs in an objective fashion, facilitated by contribution of Exploratory Analysis Plans and summary of results, in partnership with other team members.
- Collaborate with research unit scientists in the design, analysis and reporting of genetics and 'omics analyses to enable decisions on target selection and prioritization.
- Partner closely with RUs, Clinical Teams, Statistics, BT and PM functions to identify, pilot, and incorporate new bioinformatics tools to support clinical trials.
- PhD or equivalent in statistics, computational biology, bioinformatics or related disciplines with minimum of 5+ years of work experience in industry.
- At least 3 years' experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems. Pharmaceutical or biotech applications desired.
- Programming skills in R (preferred) or SAS, with expertise in big data and data visualization.
- Working knowledge of high dimensional exploratory biomarker platforms (e.g. transcriptomics.)
- Strong knowledge and understanding of statistical analytical methods that can be applied to genetics and omics data analysis.
- Strong understanding of early phase clinical study design principles including power and sample size calculations.
- Experience writing clinical biomarker SAPs
- Experience with principles of simulation, bootstrapping and permutation testing in a multidimensional modeling setting.
- Experience working in a regulatory clinical setting.
- Expertise analyzing linear mixed models.
- Expertise with exposure/response modeling.
- Demonstrated ability to develop, influence, and champion biomarker analysis strategies with scientific team audiences and management.
- Excellent interpersonal and verbal and written communication skills; ability to clearly convey statistical principles and results to non-experts. Experience presenting to multi-disciplinary scientific audiences.
- Demonstrated ability to manage projects independently, including working with other lines to prioritize tasks and gain consensus on deliverables.
- Demonstrated ability to understand and act upon strategic imperatives of organization and partner lines.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.OTHER JOB DETAILS
- Eligible for Employee Referral Award
- Eligible for Relocation Package
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