Principal Biostatistician

Name of Employer:               Parexel International LLC

Position Title:                        Principal Biostatistician  

Position Location:                275 Grove Street, Newton, MA 02466

Summary of Duties: 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 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). 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. Attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting and discussing study results).

*Remote work available*

*Position eligible for Employee Referral Program*

Qualifications: PhD in a quantitative field and 2 years of experience as Biostatistician or related role. Employer will accept a Masters in a quantitative field and 5 years of experience as Biostatistician or related role in lieu of a PhD and 2 years of experience.

Applicants must have 2 years of demonstrated experience with the following:

data collection and analysis; development and maintenance of project timelines; statistical issues in clinical trials; describing advanced statistical techniques and interpreting results; regulatory/research guidelines on drug development, GCP, and statistical principles (including ICH guidelines); SAS programming; and budget review and input.

CONTACT:  Individuals interested in applying for the position may email a resume with Job #DM0404 to openings@parexel.com

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.