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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert.
Location: United States - Remote
Key Accountabilities:
Operational Execution
Provide broad statistical support, including trial design, protocol and CRF development on specific studies
Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
Business Development
Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings
General Activities
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis
Understand, apply and provide training in extremely advanced and sometimes novel statistical methods
Contribute to the development and delivery of internal and external statistical training seminars and courses
Review position papers based on current good statistical practice
Interact with clients and regulatory authorities
Review publications and clinical study reports
Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
Additional responsibilities as defined by supervisor/manager.
Skills:
Good analytical skills
Good project management skills
Professional attitude
Attention to detail
Thorough understanding of statistical issues in clinical trials
Ability to clearly describe advanced statistical techniques and interpret results
Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
Prior experience with SAS programming required
Ability to work independently
Good mentoring/leadership skills
Good business awareness/ business development
Knowledge and Experience:
PhD or MS in Statistics or related discipline with substantial experience
The knowledge of pharmacokinetic data is an advantage
Competent in written and oral English in addition to local language
Education:
PhD in Statistics or related discipline, MS in Statistics or related discipline
