Principal, Statistical Analyst

MyoKardia   •  

South San Francisco, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 46 days ago

Key Accountabilities/Core Job Responsibilities:

  • Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
  • Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration
  • Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
  • Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
  • Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer’s Guide for Electronic Submission.
  • Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Help identify issues and initiates resolution of the problems.
  • Act as a liaison between statistical programming, subcommittees and project teams as needed.
  • May serve as external spokesperson for the organization.
  • Create/acquire tools to improve programming efficiency or quality control.
  • Keeps abreast of industry trend, best practices and improves statistical programming methodology.



Qualifications:

  • Prior macro development experience is a must.
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experienced in managing multiple projects.
  • Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).

Experience:

  • Minimum 12 years Pharmaceutical/Biotech programming experience including macro/tools development experience
  • FDA submission experience is highly desirable.
  • Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

Education Requirements (degree, certifications, etc.):

  • MS or higher degree in Statistics, Math or Computer Science