Senior Programmer I/II, Oncology

Role Overview

• Collaboration with AZ Global Product Programmer and other R&D TA team members to ensure alignment to corporate and TA standards and ensure implementation of functional best practice and lessons learned
• In-depth critical and quality review of key study documents including but not limited to: Case Report Form, SAP and FL templates, validation plans and quality documentation, STM and analysis data set specifications, compliance to data and output standards
• Plan, lead, and perform quality review or contribute to statistical programming study deliverables: SDTM and analysis (ADaM) databases, statistical reporting outputs (TFLs), including but not limited to 1. Accuracy of database structures, values and algorithms; 2, Adherence to analysis and standards requirements for study databases and TFLs 3. Accuracy and completeness of specifications and documentation
• Programming and validation of deliverables to support ad hoc analyses, site inspection, and responses to regulatory queries etc.
• Communicate technical requirements for study deliverables to biometrics vendors
• Builds and maintains effective working relationships with cross-functional teams
• Contribute to and critically evaluate management of operational and data risks within the cross-functional study team
• Contribute to the preparation and quality review of regulatory submission packages
• Identifies opportunities and contributes to the improvement of understanding and process for quality study execution
• Identifies opportunities and contributes to the development of best practice to improve quality, efficiency and effectiveness
• Mentor/coach and support the education and training of junior staffs

Requirements

• Advanced SAS programming knowledge
• 2 or 5+ years of working experience in Pharmaceutical industry
• BSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience
• Proficient knowledge of CDSIC standard and industry best practices
• In-depth Knowledge of database setup and report publishing requirements
• In-depth Knowledge of technical and regulatory requirements related to the role
• Knowledge of statistical concept
• Knowledge of the drug indications within a therapeutic area
• Experience in building and maintaining effective working relationships within teams
• Ability to lead project independently with strategical thinking and work on multiple tasks
• Ability to prioritize and project manage to optimize support.
• Excellent verbal and written communication skills
• Other programming languages are preferred e.g. R, S-PLUS, Python, XML etc

Tech Stack

• Python

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Remote work options