Clinical Data Programmer II (SDTM)

Brief Position Description:

The Clinical Programmer (SDTM) is primarily responsible for SDTM programming based on Clinical Protocols, eCRF and Statistical Analysis Plans. The Clinical Programmer (SDTM) may also be responsible for data submission packages to clients and regulators. The Clinical Programmer (SDTM) works collaboratively with the project biostatisticians, Statistical Programmers and other project stakeholders to produce quality SDTM outputs based on the eCRF design, clinical protocol and Statistical Analysis Plan.

Minimum Qualifications & Experiences:

• Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or Quantitative/Analytical fields.
• Knowledge, Skills & Abilities: SAS, SDTM Programming, Clinical Protocols and Statistical Analysis Plans
• SAS Programming Experience
• Experience in Pharmaceutical industry, CRO or related experience.

Responsibilities:

• SDTM Programming and annotation of SDTM CRF.
• SDTM Quality Control, Double Programming and Peer Review.
• Develop Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.
• Adhere to company statistical programming standards, conventions, and data standards.
• Ensure that SAS programs are properly documented and traceable.
• Maintain study documentation, programs and files within project files.
• Maintain timesheets.
• Participate in department meetings.

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 one 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.