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.

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.

2. Section

• Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
• Mentor junior staff in technical matters.

3. Software and Programming Tools

• Contribute to developing company programming conventions and SAS macros.

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