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Biometrics

Director/Senior Director, Programming

  • Cambridge, MA
  • Added
31

Position Overview:

Beam is seeking Director/Senior Director, Head of Statistical Programming to build a high-performing programming function, develop biometrics/programming related SOPs, standards, and manage and develop programming platforms and infrastructures. The ideal candidate will work closely with the head of biometrics and play a key role in the development and provide oversight to CROs to ensure timely delivery of high quality study results for Beam clinical trials.

Responsibilities:

  • Develop standard operational process, working instructions, and standards for the statistical programming group including templates for SDTM, ADaM and TLFs.
  • Develop a structure and implement solutions for clinical data repository and future data integrations across clinical trials for regulatory data submissions.
  • Manage the computing environment and statistical programming infrastructure for the biometrics department including development of SAS macros and tools, SAS maintenance and upgrade.
  • Manage internal and external programming resources including vendor oversight to ensure on-time delivery of analyses results with high quality.
  • Collaborate with Data Management to support the development of CRF, edit checks, data management plan, and data transfer plans.
  • Generate TLFs and perform ad hoc analysis as needed.
  • Support regulatory submissions and interactions with regulatory agencies.

Qualifications:

  • MS/MA in Statistics, Mathematics, Computer Science or related field.
  • 15+ years of experience in the pharmaceutical or biotechnology industry.
  • 5+ years of people management experience.
  • In-depth knowledge of SAS BASE, SAS/STAT, SAS MACRO, GRAPH, and ACCESS and technical requirements for the statistical programming environment.
  • In-depth knowledge of CDISC SDTM and ADaM specifications and related regulatory submission guidance and extensive FDA/EMA submission experience.
  • Experience managing delivery of statistical programming projects by CROs.
  • Knowledge of clinical trial design, data collection, endpoints, and standard data summary displays used in oncology, hematology, and/or cell/gene therapy preferred.
  • Strong leadership to functional development and team building.
  • Must be self-motivated, and able to work independently and effectively with colleagues and vendors and demonstrate excellent verbal and written communication skills.
  • Ability to independently manage multiple projects, prioritize and manage timelines and shifting priorities within a fast-paced company environment.
  • Familiarity with data visualization tools (Spotfire and RShiny etc.) a plus.


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