Job Description Sr. Manager/Associate Director, Statistical Programming

Role Description:

This position will provide statistical programming support for multiple clinical studies, including ad hoc requests, safety reports, manuscripts, posters, presentations with high efficiency. Oversee CRO delivery on ADaM, SDTM dataset and corresponding specification, QC key study TFL to ensure high quality data and output. Manage contract programmer.  Provide technical expertise to the development of programming standards and procedures.

Responsibilities:

  • Function as lead programmer on multiple projects
  • Provide input on key study related documents (e.g.  CRFs, Data Management Plan, SAPs, etc.)
  • Effectively develop SAS programs for study related ad hoc requests, manuscripts, posters, and presentations.
  • Create or review and approve CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies
  • Perform quality control checks the SAS program and output produced by other statistical programmers and external vendors
  • Effectively Manage multiple project assignments under challenging timelines
  • Assist in developing department SOPs related to clinical programming

Education/ Skills Required:

  • Master’s Degree or equivalent of work experience in Biostatistics, Mathematics, Statistics, Computer Science or Life Sciences
  • Minimum 7 years of pharmaceutical industry work experience with at least 2-years’ experience in oncology studies
  • Experience with all SAS language including Macro, SQL, SAS/GRAPH, knowledge of advanced SAS procedures including LIFETEST, PHREG, MIXED, GLM,
  • Experience with the CDISC, SDTM, AdaM models and transforming raw data into these standards
  • Experience working with all types of safety data and coding dictionaries (MedDRA and WHODDE).
  • Experience as a lead programmer for NDAs/BLAs
  • Experience managing direct reports
  • Experience overseeing the work of external vendors (CRO)
  • Knowledge of FDA and ICH regulations
  • Solid verbal and written communication skills