[Hiring] Principal Biostatistician @1010 Parexel International, LLC

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. • 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 • Support 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 • 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 kinds of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) • Additional responsibilities as defined by supervisor/manager Qualifications • 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 Requirements • 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 Company Description Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. • Our proven track record spans 40+ years • Advancing clinical research in healthcare’s most complex areas • Harnessing innovation to drive efficiencies across every phase of the clinical development process • Accelerating the delivery of life-changing treatments to patients — With Heart.™ Apply tot his job Apply To this Job