Manager/Sr. Manager, Clinical Programming

The Position

We are seeking a manager for clinical programming to join our growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. This is an exciting opportunity for a candidate trained in SAS programming and data analysis is who has some prior experience working as a clinical or statistical programmer, preferably within a CRO or a similar group. Prior management experience is not needed. They will initially contribute their expertise in the area of data management/clinical or statistical programming, with a goal to develop as a lead within 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 meeting 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

• Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training

• Develop or support standard operation procedure preparation

Requirements:

• Bachelor's degree in life sciences or technical field

• At least 3 years' experience of SAS programming for clinical trials for Manager; at least 5 years' experience Sr. Manager

• Working knowledge of SAS, including complex data manipulation, data presentation and output deliver systems

• Prior experience implementing edit checks and patient profiles on active clinical trials

• 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