Senior Statistical Programmer at Synteract

Position Overview

As a Senior Statistical Programmer you will provide programming support to the Biostatistics and Clinical Programming functions.  You will develops, create, verify/validate and maintain 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:

• Program study-specific start-up activities. 

• Create/review specifications for all analysis datasets (including SDTM, safety and efficacy ADaM datasets, and other safety and efficacy analysis datasets). 

• Work with sponsor and/ or statistician to review SAP, including mock shells. 

• Understand and communicate budgets and scope of work expectations to the study team.  Communicate to study team, department management and project management any concerns or deviations from expectations.  Contribute to the maintenance of Study Project Trackers. 

• Lead study team to the successful completion of simple and moderately complex projects within the parameters of timelines and budgets.  Assist leading, with guidance, complex studies or multiple study integrations (ISS/ISE). 

• Contribute to department initiatives, trainings, and standard operating procedures. 

• Participate in the evaluation and interview of new team members. 

Qualifications

Qualifications

• Bachelor's degree or equivalent in mathematics, statistics, or related field of study and a minimum of 5 years related experience or equivalent combination of education and experience.

• Advanced proficiency in BASE SAS or other statistical software. 

• Possesses understanding of data management, programming, medical writing  and regulatory issues associated with clinical trials. 

• Possesses intermediate understanding of CDISC standards and requirements.  

• Possesses a intermediate knowledge of ICH/GCP standards, 21 CFR Part 11, FDA and other applicable country regulations

If you’re passionate about bringing clinical trials to life, we encourage you to apply today!