Associate Director, Statistical Programming Lead

4 days ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Associate Director, Statistical Programming

Everest Clinical Research Services Inc is seeking a highly skilled Associate Director, Statistical Programming to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office anywhere in the USA.

Job Summary:

We are looking for a seasoned professional with expertise in statistical programming and leadership skills to manage clinical trial programs/projects from one or multiple clients. The successful candidate will provide day-to-day technical and operational leadership to project teams supporting these programs/projects.

Key Responsibilities:
  • Work with a Director, Senior Director, and/or Executive Director of Biostatistics/Biometrics to manage clinical trial programs/projects from one or multiple clients.
  • Represent the company and the Statistical Programming department in business development and client relationship management initiatives.
  • Provide leadership and oversight to the assigned client programs/projects; ensure quality, timely, and within budget deliveries.
  • Follow-up on the industry trends in data and programming standards and good programming working practices.
  • Develop and maintain clinical data and statistical reporting standards in line with pharmaceutical industry standards and conventions.
  • Coach, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.
  • Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process.
  • When required, serve as a principal level Statistical Programmer, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.
  • Perform quality control (QC) review of statistical programming deliverables, including documentation, before they are released for production, delivered to clients, or submitted to regulatory agencies.
Requirements:
  • Must have at least a bachelor degree and preferred to have M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with at least 14 years of clinical research experience.
  • Requires demonstrated experience and success in leading statistical programming teams in planning and implementing statistical programming project plans, leading programming teams to generate and deliver quality and timely deliverables within budget.
  • Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.
  • Requires demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.
  • Experience with multiple regulatory agencies preferred (FDA, PMDA, etc.).
  • Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred.
  • Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.
  • Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.
  • Exceptional written communication and presentation skills.
Travel Level Specification:

This position may require up to 10% business travel.

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