Associate Director, Statistical Programming

Our Immunotherapy client based in Lexington, MA is looking to add an Associate Director, Statistical Programming to their team (REMOTE).  Reporting to the Biometric Head, the candidate will provide statistical programming execution of clinical trials, collaborate with statisticians and data managers to ensure high quality and timely statistical programming deliverables, ensure compliance to internal standards and SOPs.  This position will serve as the in-house statistical programming expert and provide consultation to other functions.

Responsibilities:

  • Lead, guide and support statistical programming deliverables within a project to ensure high quality timely, validity, compliance to the internal standards, SOPs and regulatory requirements
  • Lead regulatory submission activities including electronic submission packages 
  • Coordinate and execute on the preparation, execution, reporting and documentation of statistical programming activities, proactively identifying issues and recommending solutions
  • Provides state-of-the-art programming knowledge/skills for process improvement initiatives or other major change initiatives.
  • Effectively monitors quality within area of responsibility, including both internal and outsourced activities.
  • Actively participates in the development and implementation of Statistical Programming objectives.
  • Enforces industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards).
  • Work closely with clinical operations, data management and statisticians to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch
  • Liaise with vendors as needed to facilitate electronic data transfers and statistical programming

Requirements:

  • MS/BS degree or higher in statistics/biostatistics or related disciplines; MS preferred with a minimum of 10+ years of statistical programming experience in pharma/biotech
  • Experience working in an outsourced statistical programming model
  • Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH)
  • Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.)
  • Prior experience filing a BLA or NDA preferred