COMPANY SUMMARY:

POSITION SUMMARY: 
This person will drive and contribute key statistical, data science, bioinformatics and genomics/genetics expertise including scientific and technical leadership to our rapidly growing Companion Diagnostics program. They will provide computational support and guidance to major initiatives such as WES, liaison the biostatistics team with bioinformatics, data science and lab-facing clients including medical affairs, scientific writer and regulatory groups. She/he will also spear-head study design, integrative data projects and visualization of large data sets, code development, analysis validation, and report generation as needed. This person will work closely with the director of biostatistics, program technical leads, and data scientists to think creatively and achieve ambitious goals to advance the treatment of cancer. 
RESPONSIBILITIES: 

• Assist the Director of Biostatistics in managing the statistical, data science other technical aspects of major initiatives as related to the purview of the department.
• Aid in managing Biostatistical response to requests for analytics that come to the department, estimating resources needed, developing SAP specifications, ensuring analysis is conducted per specifications and user needs.
• Perform and coordinate advanced biostatistical projects that require integration of possibly disparate data sources.
• Responsible for assisting with technical issues and providing solutions which are effective and cost efficient as it relates to Biostatistics, statistical programming and big-data and population cohort/genetics problems.
• Establish or enhance Standard Operating Procedures in order to maximize efficiency.
• Attend biostatistical meetings as needed. Stay abreast of the latest resource projections and availability in different regions including offshore where biostatistical and data science services and tools are provided.
• Contribute to study protocols and communicating with key stakeholders.
• Develop source code for statistical analysis and validate others code.
• Contribute to study reports and communicate results to scientists, quality assurance, and regulatory personnel.
• Adhere to standard operating procedures and work in a manner compliant with regulatory standards.
• Assist with data management when necessary.

EXPERIENCE:

• Domain expertise in NGS data/analytics, data science, including knowledge of gene-centric biomarkers and their application.
• The ability to translate a high-level requirement from life-science and executive-level clients into succinct actionable deliverables.
• Experience working in a cross-functional team with diverse expertise ranging from R&D through medical affairs, regulatory to marketing teams in a pharmaceutical, and biotech industries.
• Understanding of molecular biology, genomics/genetics, variant discovery including high throughput sequencing data and technologies.
• Familiarity with a broad range of statistical, data science and bioinformatics concepts and analyses including metanalysis and data visualization.
• Proficiency with R, Python, and/or shell programming languages in a desktop, Linux and cloud environments including knowledge of emerging data/computational technologies from AWS, Azure, Google and IBM.
• Knowledge of interacting with LIMS, CRM, Research Information management systems including KPI/Metrics design and executive presentation via dashboards platforms.
• Experience with architecting and/or deploying enterprise-wide solution for statistics, data and analytics including dealing with big-data and large population cohorts.
• Experience with data analysis in a regulated environment.
• Ability to meet goals in a fast-paced environment.