Biostatistics Director

Company: PAREXEL
Location: Youngstown
Posted on: February 23, 2021

Job Description:

The Director is responsible for statistical consulting, strategic advice and operational execution in drug/device /diagnostic developments up to submissions and approvals as well as successful reimbursement applications. The Director contributes to and leads strategic initiatives in the Biostatistics department and to build a world-class group of Biostatistics experts. The person will be recognized internally and externally as a statistical expert. Depending on experience, we may consider candidates at the Senior Principal Biostatistician level.
QualificationsSkills:
- Outstanding analytical skills
- Excellent organizational, communication, and consulting skills
- Technical leadership and contribute to a high performing team
- Expertise in optimizing trial design, development programs, submission strategies and regulatory interactions
- Outstanding understanding of the drug, device or diagnostic development process
- Expertize in broad different therapeutic areas and indications
- Thorough understanding of various statistical models and applications
- Excellent understanding of statistical issues in clinical trials and strategies to avoid them
- Thorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processes
- Thorough understanding of e-submissions, eCTD, etc
- Thorough understanding of ICH guidelines
- Excellent knowledge of all statistical and reporting processes within the Biostatistics department.
- Strategic awareness of our business environment
- Detailed awareness of the activities of other groups within PAREXEL
- Able to work with senior managers on strategic initiatives
- Highly professional attitude
- Attention to detail
- Able to work under pressure and to motivate others

Knowledge and Experience:
- Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge
- Direct experience in consulting
- Immunology experience strongly preferred
- Proven record and experience with development, execution and implementation of research strategies in the pharmaceutical industry
- Experience in designing and executing drug, device or diagnostic development programs
- Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies
- Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation
- Experience with conference presentation and manuscript writing

Education:
- Ph.D. in Biostatistics, or MSc in Biostatistics with longer working experience
EEO DisclaimerParexel is an equal opportunity employer.- Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Youngstown , Biostatistics Director, Executive , Youngstown, Ohio