Associate Director, Statistical Programming

Associate Director, Statistical Programming

We are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

• Work with a Director, Senior Director, and/or Executive Director of Biostatistics/Biometrics to manage clinical trial programs/projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
• 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. Follow-up on the latest technologies, consult with clients, upper management, peers, and subordinates to evaluate, recommend, and implement improvements to the existing company standards and good 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. These QC activities may include, but are not limited to, the following:
  • Review and confirm SDTM dataset specifications. Perform QC activities on SDTM datasets programmed by other Statistical Programmers and Biostatisticians.
  • Review and confirm ADaM dataset specifications. Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
  • Perform overall review of statistical tables, listings, and figures (TLFs).
  • Review and confirm define documents and reviewer’s guides for SDTM and ADaM datasets.
• When required, review and provide input to clinical data management deliverables including, but not limited to, electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP).
• Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

• 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…