Statistical Programmer I
Australia
Novotech
Biotech's Partner at Every PhaseLocal relationships, global executionScientific, regulatory, and medical expertise in advanced and novel therapiesDevelopment partner, sophisticated operational infrastructure, and cutting-edge...About the Role
The Statistical Programmer I role is primarily responsible for supporting statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical.
Responsibilities
- Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
- Program SDTMs, ADaMs or analysis datasets, tables, figures, and listings (TFLs) according to approved specifications.
- Adhere to company statistical programming standards and conventions, and data standards.
- Ensure that SAS programs generated for data storage, transformation, presentation and statistical analysis are properly documented and traceable.
- Maintain study documentation, programs and files within project files and maintain timesheets.
- Ensure compliance with applicable regulatory agency guidelines and Novotech’s corporate policies and SOPs, and SOPs for study design, protocol development and all other statistical programming output.
Qualifications & Experience:
- Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.
- Basic knowledge of Base SAS. Good organizational and communication skills.
- Able to perform work independently while able to establish and maintain effective working relationships with co-workers, managers and clients.
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
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.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Computer Science Data management ISO 27001 Mathematics Research SAS Security Statistics
Perks/benefits: Flex hours Medical leave Parental leave
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