Statistical Programmer II
Location
India | India
Job description
JOB DESCRIPTION
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.
Responsibilities:
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.
Section
- Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
- Mentor junior staff in technical matters.
- Software and Programming Tools
- Contribute to developing company programming conventions and SAS macros.
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.
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.
ABOUT THE TEAM
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
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