Brief Position Description:
The 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 programmers.
Responsibilities
1. Projects/Clinical Studies
- 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.
- Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
- Undertake peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required.
- 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.
- Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
- Mentor junior staff in technical matters.
- Contribute to developing company programming conventions and SAS macros.
2. Section
3. Software and Programming Tools
4. Statistical Programming Processes and SOPs
- 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.
Minimum Qualifications & Experience:
Minimum Master’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.1-year relevant experience required or a 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 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 talking to you about working at Novotech.
ResponsibilitiesResponsibilities1. Projects/Clinical Studies- 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.
- Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
- Undertake peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required.
- 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.
- Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
- Mentor junior staff in technical matters.
- Contribute to developing company programming conventions and SAS macros.
- 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.
Minimum Master’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.1-year relevant experience required or a 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
About UsNovotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
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.
