Director of Biostatistics

Proclinical is currently recruiting for a Director of Biostatistics with a global CRO company located in Raleigh, NC. Successful candidate will be responsible for the efficient function of the Biostatistics department to ensure deliverables of high quality are produced within the agreed upon timelines. Individual will also work with internal team members, senior management and business development on issues and questions of any biostatistical nature, coordinate and manage the internal and external advisors and consultants to the company, and ensure statistical materials including tables, listings, graphs and statistical analysis plans produced by the company are appropriately reviewed and approved in accordance with SOPs and GCP.

Job Responsibilities:

• Plan and implement quality checks for clinical operations within the region.
• Lead operational activities of the Biostatistics Department.
• Evaluate workloads, resources, process, and technology for efficient operation of the department.
• Ensure systems are in place to produce quality work efficiently, allowing for continual growth of the department.
• Consult with project teams, sponsors, and FDA on project-related issues.
• Provide input to the statistical and programming portions of RFPs.
• Serve as a statistical consultant both inside and outside the company.
• Function as lead biostatistician on projects, as necessary.
• Collaborate with all Departments within the company.
• Collaborate with the company Medical Director, Support Services and Quality Assurance personnel.
• Liaise with Sponsor and sub-contractors.
• Collaborate with company Project Managers and other project team members.
• Collaborate with line management of project team members.

Skills and Requirements:

• MS/PhD in statistics biostatistics or a related field.
• PhD in statistics, with 12+ years of experience in pharmaceutical industry, or CRO or a MS/MPH in statistics or biostatistics with 15+ years of experience in pharmaceutical industry or CRO as a leading statistician in the design and conduct of Phase I-IV clinical trials.
• Ability to lead in a multi-disciplinary team setting.
• Proven performance of required tasks, as evidenced by outstanding performance in current tasks and/or documented record of accomplishments.
• Evidence of strong management skills, as shown through management of multiple projects and staff members.
• Demonstrated initiative and motivation.
• Good organizational skills, with the ability to adapt and adjust to changing priorities.
• Positive attitude and the ability to work well with others.
• In-depth working knowledge of Phase I-IV clinical trials.
• Knowledge of regulatory requirements of clinical trials.
• Excellent written and verbal communication skills.
• Ability to communicate complex statistical concepts to non-statisticians.
• Ability to travel domestically and internationally as required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Susan Chapman at (+1) 646-542-0158 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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