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Title:Associate Director, Statistical Programming
Salary:Open
Experience:2-7
Location:NJ - Northern

Description:
The Associate Director, Statistical Programming will ensure that resources are well planned and appropriately allocated to all assigned projects based on staff availability, skills, and timelines.

Responsibilities:
  • Develop relationships within BPSS and across CDMA functions such that business needs are satisfied.
  • Stay abreast of current regulatory environment focusing on submission standards.
  • Assist the Head of Statistical Programming in identifying appropriate software to support all statistical programming activities.
  • Assist the Head of Statistical Programming in developing accurate budgets based on predicted project workload.
  • Work with other functions within BPSS and CDMA to ensure compliance with reporting standards are followed.
  • Hire and train highly competent staff that are capable, willing, and motivated to accomplish their responsibilities.
  • Develop staff for current and future positions.
  • Assist the Head of Statistical Programming in ensuring that the business needs and partner organizations are satisfied with respect to statistical programming activities and the exchange of data sets for clinical studies.
  • Support the Head of Statistical Programming in managing Statistical Programming group to achieve the goals of BPSS and CDMA.
  • Ensure that all statistical programming processes are adequately documented.
  • Assist the Head of Statistical Programming in ensuring that all computer systems in the statistical programming environment are adequately validated based on FDA regulations/guidances.
  • Make sure that all members of Statistical Programming receive appropriate performance management.

Requirements:
  • Masters degree in Statistics, Biostatistics, Mathematics, Computer Science, or another related field.
  • Minimum of 7 years experience in statistical programming and NDA preparation.
  • Minimum of 2 years managerial experience in statistical programming.
  • Knowledge of SAS, CDISC, and a thorough knowledge of good programming practices and methodology.
  • Good understanding of FDA regulations and guidances regarding statistical programming.
  • Strong communication skills: oral, written, and effective listening.

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