Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.

Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas.

Our people are critical in meeting organizational, and client objectives and we place a strong emphasis on creating a collaborative, transparent, and inclusive work environment where everyone is supported to achieve.

Due to continued growth, we are looking for a talented Principal Statistical Programmer to join the Biometrics team 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

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.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.