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Title:Associate Manager Statistical Programming
Location:NJ - Bridgewater

Oversees and manages all activities related to statistical and non-statistical analysis related to ongoing clinical studies.  Plans and establishes approaches for coding programs, and implements the best practices for program documentation and programs for computer operations. Interacts with various internal and external vendors as well as clinical and regulatory staff and partners. Must be able to deliver statistical related requests effectively for department head as needed. Oversees documentation and ensures consistent maintenance of code, logs, and output within a regulated environment. Evaluates information generated by supervised staff for validity, quality and effectiveness of presentation.

  • In conjunction with department head, provides input on the strategic direction for statistical and non-statistical analysis in relation to ongoing clinical studies.
  • May be responsible for managing work of statistical programmers and providing guidance.
  • Interfaces with other groups within SDMI and integrates processes to ensure efficiencies and appropriate communication.
  • Communicate data results to Clinical departments.
  • Provides input and expertise to ensure compliance with applicable regulations.
  • Provides input for study design and analysis of clinical data.
  • Provides input for statistical analysis plans, clinical study reports, and summarizes key results as needed.
  • Identifies data quality issues, and recommends and implements solutions to resolve those issues.
  • Develops sophisticated analytics and data model in support of clinical trials.
  • Integrates data from various sources for use in the integrated analyses.
  • Serves as lead for provision of data and statistical information from clinical trial results
  • Manages documentation and validates results generated.
  • Manages and generates assorted tables and analyses as required for internal and external use.
  • Writes SOPs pertaining to statistics and statistical programming, as needed.
  • Checks codes written by other Statistical Programmer(s) and performs quality control checks to ensure codes work according to program design.

  • Bachelor's degree (Master's degree helpful).
  • Six (6) years of relevant SAS programming in a biotechnology or pharmaceutical company.
  • SAS Certification (desirable).
  • Knowledge of statistics a must as well as proficiency in Excel and Word.
  • Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
  • Flexibility and multi-tasking are highly desirable skills for this position.
  • Strong command with SAS, (Base, Stat, Macro, graph) and JMP with GUI interface.
  • Knowledge of related regulatory guidances as well as industry standards, such as ICH Guideline and CDISC data standards.

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