Associate Director, Statistical Programming

Manage and coordinate the Statistical Programming staff to maintain work flow for programming efficiency.

Design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.

Contribute to and champion best practices to enhance the value and contribution of Programming across other therapeutic areas.

Responsibilities

  • Lead on clinical studies and manage/provide training to lower level personnel when needed.
  • 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.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
  • Other duties as assigned.

Qualifications

  • Minimum 12 years Pharmaceutical/Biotech programming experience with two years of people management experience.
  • Ability to use professional concepts to achieve objectives in innovative and efficient ways.
  • FDA submission experience is a must.
  • Solid knowledge of CDISC standard (SDTM & ADaM).
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus. 
  • BS/MS in Statistics, Math or Scientific Discipline

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com

Equal Opportunity Employer