Director, Biostatistics Job Description

Director, Biostatistics Job Description Template

Our company is looking for a Director, Biostatistics to join our team.

Responsibilities:

  • Contribute to clinical development plan preparation;
  • Development of detailed Medpace Data Analysis Plan for assigned projects;
  • Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and;
  • Review of study protocol and preparation of statistical methodologies;
  • Programming of study analysis, review of study results and preparation of statistical methods section for clinical/statistical reports;
  • Plan and implement quality checks for clinical operations within the region;
  • Collaborate with line management of project team members;
  • Collaborate with company Project Managers and other project team members;
  • Serve as a statistical consultant both inside and outside the company;
  • Evaluate workloads, resources, process, and technology for efficient operation of the department;
  • Function as lead biostatistician on projects, as necessary;
  • Collaborate with all Departments within the company;
  • Liaise with Sponsor and sub-contractors;
  • Ensure systems are in place to produce quality work efficiently, allowing for continual growth of the department;
  • Lead operational activities of the Biostatistics Department.

Requirements:

  • areas to ensure that Alexion’s clinical programs are optimally designed, properly analyzed and;
  • Participates in establishing and maintaining policies, standards, and procedures for global Biostatistics;
  • Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic;
  • Provides statistical consultations and strategic inputs in terms of drug development for cross-functional teams within the company;
  • Demonstrated initiative and motivation;
  • Excellent written and verbal communication skills;
  • MS/PhD in statistics biostatistics or a related field;
  • Previous supervisory experience preferred;
  • In-depth working knowledge of Phase I-IV clinical trials;
  • Proven performance of required tasks, as evidenced by outstanding performance in current tasks and/or documented record of accomplishments;
  • Ability to communicate complex statistical concepts to non-statisticians;
  • Positive attitude and the ability to work well with others;
  • Excellent analytical, written and oral communication skills; and;
  • PhD in Biostatistics/Statistics preferred;
  • 5-10 years pharmaceutical clinical trials experiences, CRO preferred; and.