Responsibilities :
- Develop, test and run SAS programs for statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings.
- Specification of table templates, writing of derived dataset specifications, production and formatting of tables and figures.
- Develop, test, document and update SAS macros for the generation of summary and statistical analysis tables and figures for reports.
- Develop SAS programs / macros for data cleaning and liaise with Data Management team in identifying and implementing checks according to the Data Validation Plan.
- Perform ad hoc programming tasks to assist with data review and produce ad hoc summaries when requested during the course of a clinical study.
- Document standard SAS programs to further develop quality of code and efficiency throughout the reporting and data validation processes.
- When necessary, develop SAS programs for external data transfer.
- Liaise with IT and external software providers on the procurement and installation of new software.
- Validate software in the role of system tester, maintaining the required validation and testing documentation.
- Provide technical support and mentoring for colleagues.
- Prepare, maintain, and archive programming documentation.
- Establish and maintain SOPs related to programming.
- Implement programming process improvements and identify opportunities for improving the efficiency and quality of work within Clinical Affairs.
- Remain up to date on new SAS developments relevant to clinical study data and further develop knowledge of SAS (Base and SQL) and other software applications ( Excel, visual basic), clinical data management and statistical reporting activities.
- Develop regulatory standards knowledge in computer systems, systems validation, GCP, CDM, clinical / statistical reporting and regulatory submission requirements.
- Contribute to on-boarding of new associates and act as a mentor for junior staff.
Requirements :
- Degree in a relevant field (necessary).
- A minimum of years' experience in the Clinical Research / Statistical Programming environment (necessary).
- Strong experience with data and production of Tables, Figures and Listings (necessary).
- Strong SAS programming and logic skills (necessary).
- Thorough understanding of CDISC standards (desirable).
- Thorough knowledge of clinical database structures (desirable).
- Experience in medical device, pharmaceutical or CRO industry (desirable).
- Experience of clinical trials involving medical devices (desirable).
- Proficient with MS Office applications (desirable).
- Excellent organizational and communication skills (desirable).
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