Staff Statistical Analyst # 3740

Responsibilities

• Provide statistical programming support to pre-specified and exploratory analysis, formal reports, publications, presentations, and new statistical methodologies
• Work closely with biostatisticians to review the statistical analysis plan (SAP), and create data and analysis program specifications based on the SAP
• Maintain complete and auditable programming documentation for analysis of clinical studies
• Contribute to the development, documentation and maintenance of a reusable programming code library
• Serve as a member of clinical study teams
• Work with data scientists closely on machine learning projects, as applicable
• Work on engineering-oriented projects like dashboarding, automation, and scaling up efforts with large-scale genomic data, as applicable
• May act as a biostatistician on small-scale projects
• Stay abreast of industry developments in the Statistical Programming field and apply to appropriate systems and processes

Preferred Qualifications

• B.S. or M.S in Statistics or related field or equivalent
• 5+ years statistical programming experience in academia or industry. Molecular diagnostics industry experience preferred.
• Proficiency in R is required or experience programming in SAS with FDA regulatory experience.
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
• Experience with vcf, CDISC, SDTM, and ADaM compliant data sets is strongly desirable
• Experience with regulatory submissions is strongly desirable
• Ability to work independently on multiple concurrent projects in a fast-paced environment
• Strong team player with demonstrated track record of success in cross-functional team environment

Desired experience

• Molecular diagnostics industry experience preferred
• R is strongly preferred
• Regulatory filing experience is strongly preferred