Statistical Programmer II

Job title: Statistical Programmer II

Company: Novotech


Job description: Job Description:About the RoleThe Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers and/or Statistical Programming Management. The SP II works closely with the project biostatisticians and other project stakeholders to plan and assist with leading the development of project-related solutions. The SP II provides support and mentorship to junior programmersResponsibilities

• Review a clinical study protocol with regards to statistical programming responsibilities.
• Assess study related workload and project timelines and discuss programming time estimates and risk mitigation plans with Statistical Programming Team Lead for inclusion in resource forecasts.Review and provide input to Case Report Forms (CRFs) and External Data Transfer Agreements.
• Program SDTMs, ADaMs, Tables, Figures, and Listings (TFLs) according to approved specifications.
• Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects and peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required
• Contribute to developing company programming conventions and SAS macros..

Qualifications & Experience:

• Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field
• 2-years of experience in pharmaceutical industry, CRO or related experience using SAS programming in clinical studies.
• Able to independently perform technical work. Good SAS programming skills. Knowledge of CDISC standards.

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 applicationAbout Us:Novotech is a global full-service clinical Contract Research Organization (CRO).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 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:At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.

• Ability to gain insights and make proactive decisions quickly.

• Culture that fosters partnership and collaboration, where every voice is heard and valued.

• Ongoing support from senior stakeholders and leadership team.

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Expected salary:

Location: Australia

Job date: Tue, 08 Apr 2025 22:45:46 GMT

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