Novotech Australia Pty Limited N

Principal Statistical Programmer (BB-9D0CE)

Found in: Fidanto AU

Description:
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. Due to continued growth within the Biometrics team, we are looking for a talented Principal Statistical Programmer to be office or home based within Australia. The purpose of the role is to develop and standardise re-usable program code for the purpose of undertaking data validation, and for generating tables, listings and figures TLFs which are part of interim and final reports, in accordance with applicable regulatory guidelines and using validated statistical software environments, in particular SAS. Responsibilities Provide input into statistical analysis plans with respect to presentation of data and results tables, listings, figures and advise project staff with requirements in relation to data collection, storage and tabulation CDASH, SDTM, ADaM Interprets specifications, technical designs and flow charts, builds, maintains and modifies the code for software applications, constructs technical specifications from a business functional model, and tests and writes technical documentation. Develop and validate SAS programs for the tabulation of data, preparation of subject listings, graphical output and statistical analysis of data. Develop and maintain a library of validated programs based on CDISC CDASH, SDTM, ADAM , and regulatory guidance for data submissions, in particular FDA. Act as Project Programmer for assigned projects involving multiple studies, and ensure consistency in data structuring and presentation Act as mentor to junior statistical programmers and conduct training activities Experience and Qualifications Degree in statistics, mathematics, biostatistics, computer science or life sciences with demonstrated programming experience in the fields of biostatistics or pharmacometrics. Highly experienced as a Statistical Programmer within a pharmaceutical company or CRO. High level of proficiency with SAS software, R, and other statistical analysis or data visualisation software packages. Fluency in English and excellent verbal and written communication skills are essential Adaptability, team work and collaboration are essential Find out more about working at Novotech at www.novotech- 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. Report this job advert

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location_on Melbourne, Australia

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