September 15, 2016

Principal Biostatistician

PAREXEL - Waltham, MA

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  • Company
  • Location
    Waltham, MA
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Mid-Career (2 - 15 years)
  • Education
    Masters Degree
  • Company Ref #
  • AJE Ref #

Job Description

PAREXEL currently has a career opportunity for a Principal Biostatistician. The Principal Biostatistician works independently on all level complex clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. The Principal Biostatistician will lead projects and drive timelines and deliverables within the team.Key Accountabilities
- 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
- Review publications and clinical study reports
- 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
- 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.
- Support of Business Development, e.g. 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.
- 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/managerQualifications
- Good analytical skills and project management skills
- Professional attitude and 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 require
- Ability to work independently and Good mentoring/leadership skills
- Good business awareness/ business development
- Experience with CDISC is a plus Education - PhD in Statistics or related discipline with 3+year experience or MS in Statistics or related discipline with 5+ years of experience Language Skills - Competent in written and oral English in addition to local language Minimum Work ExperiencePhD in Statistics or related discipline with 3+year experience or MS in Statistics or related discipline with 7+ years of experienceSubmissions experience would be a plusIndustry experience; Biopharmaceutical or CRO Travel 10-15%EEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.