Manager, Statistical Programming

Compensation Description

The base salary range for this position in the selected city is $90,000 - $130,000 annually.

The Position

We are seeking a manager for statistical programming to join our growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio. This is an exciting opportunity for a candidate who has extensive experience working as a clinical programmer in the pharmaceutical industry or a CRO. Prior management experience will be beneficial. They will initially contribute their expertise in advanced clinical programming, with the goal to develop as a leader of the clinical programming team.

Responsibilities

• Work with data managers to develop data review plans to ensure data cleanliness
• Implement SAS-based edit checks to implement data cleaning to ensure data of the highest quality
• Code programs to help reconcile inbound vendor data transfers against clinical database records
• Deliver programming results for ad-hoc analysis requests by statistics
• Assist with the evolution of the clinical programming computing architecture, and delivery methodology
• Develop programs for use by the safety monitoring department to ensure safety surveillance and signal detection
• Review outputs and data transfers provided by CROs for accuracy and consistency with specifications and CDISC Standard
• Manage vendor oversight to ensure quality deliverables
• Participate in study team meetings and support data-cleaning activities
• Lead in efforts to identify, develop, and implement departmental standards, applications, processes, and training
• Act as a subject matter expert for data standards
• Serve as an inter-departmental subject matter expert for the Clinical Programming area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
• Ensure compliance with relevant departmental SOPs and ICH/GCP guidelines

Requirements:

• Bachelor’s degree in computer science/biostatistics/statistics/public health or similar field
• Extensive understanding of clinical trials
• Advanced knowledge of SAS, including complex data manipulation and basic analysis procedures

• At least 3 years experience in clinical programming under the pharmaceuticals/biotech clinical development or CROs.
• Working knowledge of Rave
• Familiarity with CDISC standards, derivation of SDTM and ADaM specifications
• Experience with external data vendor management and oversight
• Strong Project Management skills

• Excellent verbal and written communication skills

Preferred:

• Exposure to Spotfire or other data visualization platforms
• Exposure to cloud environments (e.g., Azure), data lakes, ingestion/transformation mechanisms (e.g., data pipelines)
• SAS Certification