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.