Job Description

Job Description The Principal Biostatistician is primarily responsible for implementing and executing methodological and statistical aspects of clinical studies. The Principal Biostatistician has the responsibility to design, develop, and evaluate clinical trials, monitor statistical analysis, and develop systems to determine the efficacy of clinical trials. Job Responsibilities Perform or supervise complex statistical analyses and create or provide input to statistical reports. Cooperate with other company departments to optimize the global efficiency. Act as a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle. Define strategies and evaluate the statistical resources needed to meet the defined project goals. Coordinate Biostatistics related project activities for successful completion within given timelines and budget. Interact with internal and external clients with regard to data analysis, scope of work, and budget. Ensure compliance with applicable regulatory agency guidelines and Novotech SOP's in study design, protocol development and all other statistical output. Perform protocol development, sample size calculation, protocol and CRF review. Write statistical sections of integrated reports. Review derived datasets and all types of statistical analysis deliverables. Develop complex analysis strategies and execute them using efficient programming techniques. Produce and provide expert input to analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents. Quality control of all kinds of statistical deliverables. Training/mentoring of junior members of the department. Representing Novotech at client meetings. Participation in industry forums (conferences, professional association committee work etc.) as a means of professional development as well as promotion of Novotech's image in industry. Job Requirements Master's or PhD with a major in statistics/biostatistics or related field with over 10 years of pharmaceutical industry, CRO, or related experience. Experience leading Phase 3 programs and regulatory strategy study and design for Phase 3 programs. Proficiency with Microsoft Office tools (e.g., Word and Excel) and standard statistical packages (SAS TM) is expected. Salary Band - $140,000-165,000 Salary offered will be based on candidates experience level. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. About Us Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. About the Team Novotech is a global full-service clinical Contract Research Organization (CRO) and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance. Novotech

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