Principal Biostatistician

As a Biostatistician at Parexel you’ll work on a variety of projects, while collaborating with our global team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas, become involved in business development activities, and have the opportunity to grow and develop your career within a flexible working environment. You’ll also contribute to research design and analytical strategies, provide input into protocols, and develop and review statistical analysis plans. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
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**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Analytical
- Communicator
- Leadership
- Efficient
- Tech-Savvy
- Personable

**Rewards**:

- **Career Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Balance**: We value work-life balance. We try and keep regular hours and a flexible working enviroment.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Systems**: Utilize Parexel’s industry leading clinical systems and solutions
- **Mentoring program**: Strong mentors with depths of experience working for global health authorities.

**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, eg 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
- 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 (eg 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

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