Statistical Programmer at Synteract

The Statistical Programmer provides programming support to the Biostatistics and Clinical Programming functions. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. At higher levels the statistical programmer roles are expected to contribute to the improvement of overall department process and efficiencies through mentorship and identifying and contributing to departmental initiatives.

Specific Tasks Would Include

• Create and maintain SAS programs for safety analysis datasets (including SDTM, ADaM, and other analysis datasets) and safety tables and listings used in the analysis and reporting of clinical trial data.
• Perform programmatic validation of safety SDTM datasets and data listings used in the reporting of clinical trial data.
• Create and review Pinnacle 21 reports and investigate as necessary.
• Maintain study documentation according to Standard Operating Procedures.
• Document and communicate data issue findings to data management through recording them in the data issue log.
• Awareness of time available to complete tasks and work with study lead and manager to manage effort.
• Assist with ad-hoc programming as requested.
• Regularly participate in ongoing department training and development opportunities.

Degree And Experience

• Bachelor's degree or equivalent in mathematics, statistics, or related field of study and some related experience or equivalent combination of education and experience.

Specific Knowledge

• Possesses a basic knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Basic proficiency in BASE SAS or other statistical software is advantageous, but not required. Statistical Programmer levels
• Understands the sequence of running programs to ensure up-to-date data, to troubleshoot and debug programming problems, and to identify data trends.
• Proficiency in Microsoft Word, Excel, PowerPoint, Access, and Outlook.
• Effective verbal and writing skills; English + local language, if relevant.