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Statistical Programming Technical Manager

Penfield Search Partners Plainsboro, NJ
  • Posted: over a month ago
  • Full-Time
Job Description

Contact: Linda Aronova - 646.882.9021 - laronova@penfieldsearch.com
Summary: The Global Biometric Sciences (GBS) Statistical Programming Technical Manager provides functional expertise and leadership to Statistical Programming and Data Science (SP&DS) colleagues while delivering comprehensive programming expertise to clinical project teams in support of development, regulatory approval, and market acceptance of company products. This position is primarily responsible for the designing, developing and implementing technical solutions for integrating, analyzing and reporting clinical data. Includes using SAS, R, and other statistical software packages.
Responsibilities

  • Ensures quality of GBS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
  • Provides comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, corporate and departmental SOPs and work practices
  • Drives the development and implementation of innovative strategies and technologies for clinical trial programming
  • Provides technical guidance to vendors around project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project computing strategies
  • Reviews planning documents (e.g. statistical analysis plans, data presentation plans, data review plans) to ensure alignment with development team objectives. These reviews focus on clarity, integrity and completeness of programming assumptions and requirements, and ensure compliance with standards
  • Develops unambiguous and robust programming specifications for internal and external programming work
  • Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and company standards
  • Understands software development methodologies and appropriately applies those methodologies
  • Identifies opportunities for increased efficiency and consistency within GBS and provides leadership and support to improvement initiatives

Qualifications

  • Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
  • Minimum of 6 years clinical/statistical programming experience within pharmaceutical clinical development
  • Extensive knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
  • Broad expertise in statistical programming and developing computing strategies for statistical analysis & reporting within the pharmaceutical industry
  • Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing technics
  • Ability to work successfully within cross-functional teams leading by developing and maintaining successful partnerships
  • Demonstrated ability to flexible and adapt quickly to changing needs within an organization
  • Demonstrated ability to organize multiple work assignments and establish priorities
  • Communicates proactively and effectively; excellent verbal and written communications skills
  • US military experience will be considered towards industry and professional experience requirements.

Penfield Search Partners

Address

Plainsboro, NJ
USA

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