Manager, Clinical Programming

Responsibilities

• Develop, and execute edit checks and patient profile software or programs for clinical trials;
• Develop and execute data listing programs used by data managers, safety surveillance, medical or clinical operations personnel;
• Collaborate with data management to ensure appropriate data collection and reporting. Participate in study team meetings and support data management activities;
• Program and deliver results on time for ad-hoc data programming requests;
• Define and help implement statistical computing environment, specifically SAS server setup and work practices;
• Support statistical programming, from raw data to ADaM, of efficacy and safety evaluation;
• Interface with CRO and perform quality audits on CRO outputs. Review outputs provided by CROs for accuracy and consistency with the programming specs;
• Affirm or support standard operation procedure preparation.

Requirements

• Bachelor’s degree in life sciences or technical field;
• At least 5 years’ experience of SAS programming for clinical trials;
• Prior experience implementing edit checks and patient profiles on active clinical trials;
• Working knowledge of SAS, including complex data manipulation, data presentation and output deliver systems;
• Excellent verbal and written communication skills.

Preferred

• Familiarity with CDISC standards, derivation of SDTM and ADaM specifications;
• Data management experience;
• Proficiency in R;
• CRO experience.

California Pay Range

California pay range: $120,000 USD - $140,000 USD