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
EEO Disclaimer
Parexel 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.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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