AddressMinimum Qualifications & Experience:
Minimum bachelor’s degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in quantitative/analytical field with a minimum 7 years of experience in Pharmaceutical industry, CRO or related experience using SAS programming in clinical studies, including leading a clinical study or project programming team. Able to independently perform technical work. Exceptional SAS programming skills. Knowledge of CDISC standards and applying standards to different study phases, study designs and therapeutic areas.
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.
- Review and provide input to a Statistical Analysis Plan (SAP) with respect to presentation of data and results (tables, listings, figures).
- 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.
- Assess requests for changes to SAP, Tables, Listings, Figures, and SDTM/ADaM or analysis datasets specifications, and discuss with Statistical Programming Team Lead for inclusion in resource forecast and change orders (Change Management).
- Participate in audits.
- Maintain study documentation, programs and files within project files and maintain timesheets.
- Represent Novotech at client meetings as required.
2. Clinical Product Development
- Undertake gap analysis across the clinical study databases that need to be part of the data package with respect to the standardization and transformation efforts required.
- Develop project plan to generate the package and estimate costs in consultation with Line Manager and Biostatistics.
- Develop programs to generate SDTM datasets, SDTM annotated CRF, AdaM datasets, Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.
3. Section
- Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
- Mentor junior staff in technical matters and assist in induction of new staff.
4. Software and Programming Tools
- Contribute to developing company programming conventions and SAS macros.
- Assess impact of new software releases and patches of SAS on ongoing projects.
- Contribute to automating statistical programming tasks and progress tracking.
- Advise Clinical Data Management and Clinical Data Programming with respect to CRF libraries and data dictionaries based on CDASH and SDTM.
5. Statistical Programming Processes and SOPs
- Contribute to the development and updating of SOPs and best practices, process improvement, quality control and governance related to all statistical programming matters.
- 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.
