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May

Biostatistician

Novotech - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Biostatistician | AU

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.

Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.

Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary careers, and regular training, learning, and international knowledge-sharing opportunities.

The Biostatistician will primarily implement and execute methodological and statistical aspects of clinical studies

Responsibilities

  • Design, analysis, review and interpretation of clinical trial data
  • Review available literature and implement appropriate statistical methods
  • Ensure compliance with applicable regulatory agency guidelines in study design and protocol development
  • Participate and review and/or preparation of statistical sections of study synopses, protocols and study reports
  • Prepare sample size estimations, and prepare sample size justifications
  • Review of case report forms and data management plans to ensure efficient and accurate collection of data
  • Prepare randomisation specifications and schedules, and liaise with EDC vendors, or third parties, to set up IWRS/IVRS randomisation where applicable
  • Prepare and write statistical analysis plans
  • Write, document, validate and execute statistical programs using SAP or other software as required
  • Interact with project managers, data managers and clients from start up through to close out
  • Provide methodological advice to team and client
  • SAS programming of derived datasets, tables, listings and figures according to the SAP and mock templates
  • Quality Control of SAP output
  • Ensure quality of statistical data and reports generated
  • Present findings to internal/external clients as required
  • Assist business development on forecasting statistic resource needs for ne study bids


Experience And Qualifications
  • Masters or PhD with a major in statistics or biostatistics or related field with 2-5 years of pharmaceutical industry, CRO or related experience
  • Proficiency with Microsoft Office tools ( eg Word and Excel) and standard statistical packages (SAS) is expected


Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is committed to offering Equal Employment Opportunities (EEO) where everyone has equal access to employment opportunities based on merit, without fear of discrimination or harassment.

Sydney, NSW

Health, Medical & Pharmaceutical




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