Lead Biostatistician - Patient-Reported Outcomes Expert

About the Role We are excited to invite a Lead Biostatistician to join our dynamic team, specializing in Patient-Reported Outcomes (PRO) within clinical trial projects. This remote opportunity offers you the chance to work independently while driving innovative statistical strategies across diverse studies that have substantial regulatory significance. As a recognized authority in the field, you will be instrumental in collaborating with both internal teams and external partners. Key Responsibilities Deliver extensive statistical support, encompassing trial design, protocol formulation, and CRF development for various clinical studies. Oversee the creation and quality assurance of essential documentation including randomization schedules, statistical analysis plans, and statistical reports. Execute sample-size calculations, generate randomization lists, and draft the statistical methodology sections for study protocols. Participate in Data Monitoring Committee (DMC) activities, aiding in the development of DMC charters and statistical analysis plans. Play a key role as a non-voting independent statistician, preparing data and analyses for DMC reviews. Emphasize Patient-Reported Outcomes (PRO) in all statistical analyses undertaken. Business Development Assist Business Development initiatives by engaging in study design discussions during meetings with clients and internal colleagues. Provide sample-size scenarios and support proposal and budget formation. Prepare for and actively participate in bid defense meetings. General Activities Comprehend and apply regulatory requirements across various therapeutic areas, understanding their implications on statistical methodologies. Stay informed on advanced and emerging statistical methods, offering training as necessary. Contribute to the development and execution of internal and external statistical training seminars. Review publications and clinical study reports to ensure adherence to statistical best practices. Engage with clients and regulatory agencies to present insights and findings. Travel to client meetings as required to discuss analysis concepts and present study results. Take on additional responsibilities as assigned by management. Skills and Qualifications Exceptional analytical skills paired with strong project management capabilities. Impeccable attention to detail and a polished professional demeanor. Deep understanding of statistical challenges and methodologies in clinical trials. Ability to effectively communicate complex statistical techniques and interpret results for diverse audiences. Familiarity with regulatory guidelines related to drug development, including GCP and ICH principles. Prior experience in SAS programming is essential. Proven ability to work independently and mentor junior team members. Strong business insight and capacity for engaging in business development activities. Education and Experience PhD or MS in Statistics or a related field, accompanied by significant relevant experience. Knowledge of pharmacokinetic data is considered a plus. Fluency in both written and spoken English, along with proficiency in any applicable local languages. Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

Created: 2026-03-04