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Title:Associate Director, Biostatistics
Salary:Open
Experience:7+
Location:NJ - Princeton

Description:
This is a senior level technical position. The incumbent is responsible for the delivery of statistical support to NNIs clinical development, registration, and marketing of new drugs. Functions include clinical trial design, data analysis, report writing, general consultations, project planning and execution.

Responsibilities:
  • Reports to the Director, Biostatistics.
  • Works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers.
  • May be required to represent the Director of Biostatistics in internal and external interactions.
  • May be required to supervise junior staff for specific tasks based on project needs.
  • Coordinating with the Director, prioritize task assignments, timelines, supervisory of junior technical staff, and outsourcing management.
  • Manage the interactions with NNA/S headquarters statistical group through department Director.
  • Under coordination of the Director, participate in meetings or communications with the regulatory agencies (primarily the FDA).
  • For assigned projects, manage the relations with NNI internal customers, including clinicians, medical writers, regulatory staff, and marketing managers.
  • Coordinating with the Director take full responsibility for assigned clinical development projects.
  • Assure that statistical and scientific methodologies are fully considered and documented.
  • Participate in the review of study protocols, critique and suggest improvements on scientific methodology.
  • Write statistical sections.
  • Develop plans and perform statistical analysis and presentation.
  • Participate in the interactions with medical development, medical writing, regulatory affairs, and regulatory agencies.
  • Assure statistical input, analysis, and reports of the highest quality are delivered according to schedule.
  • Perform hands-on programming or direct statistical programming staff assuring that data listings, tables, and graphs are produced with highest efficiency and quality.
  • Guide and participate in the development and maintenance of statistical routine libraries.
  • Participate in the development and update of internal SOPs and working procedures.
  • Assist the Director lead the department staff, keeping abreast of current statistical literature, assuring the most current regulatory requirements are followed and sound methodologies are adopted.
  • Keeping abreast of and observing general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.

Requirements:
  • PhD degree in Biostatistics, Statistics, or relevant areas required.
  • Seven years (7) of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility.
  • Extensive knowledge of statistical concepts and techniques and of clinical trial principles.
  • Extensive knowledge of statistical computer programming skills.
  • Excellent communication, interpersonal and organization skills.

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