Sr. Director, Statistical Programming

Boston Biomedical is seeking a Sr. Director in Statistical Programming. The Senior Director leads the Statistical Programming function and provides strategic, technical and operational oversight for Statistical Programming support for all clinical development programs at Boston Biomedical. He/she is also responsible for ensuring effective statistical programming support for regulatory, medical affairs, and market access needs. This position is responsible for resource planning/allocation, vendor management, timeline management, and recruiting, retaining, managing, and mentoring statistical programmers.

Reporting Relationship:

Head of Biostatistics

Key Responsibilities

  • Leads the Statistical Programming function
  • Provides strategic, technical and operational oversight for the statistical programming support for all clinical development programs
  • Builds efficient processes and standards to accelerate worldwide product approvals, including design and infrastructure of statistical programming environment and authoring of SOPs. Ensures compliance with SOPs
  • Lead as CDISC expert at Boston Biomedical being accountable for regulatory submission of electronic datasets
  • Provides resource planning/allocation, vendor management, timeline management, and recruiting, retaining, managing, and mentoring statistical programmers

Professional Experience / Qualifications

  • Excellent written and oral communication and presentation skills
  • Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards
  • Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submissions
  • Expertise in CDISC including SDTM, ADaM and CDASH
  • Advanced knowledge of SAS programming skills including SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures.
  • Knowledge of R programming is a plus
  • Master’s degree, preferably in Biostatistics (or equivalent)
  • At least 12 years experiences in pharmaceutical statistical programming
  • Extensive experience in BLA, NDA/s NDA regulatory submissions is required
  • Experience in people management is a plus
  • Experience in developing and implementing SOPs is a plus

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com