Principal Statistical Programmer
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 (e.
g. 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 7 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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