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