
Senior Programmer I/II
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Shanghai • 🇨🇳 China
Visit company websiteJob Level
Senior
Tech Stack
Python
About the role
- 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 contribute 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 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
- Knowledge of other programming languages e.g. R, S-PLUS, Python, XML
Benefits
- AstraZeneca embraces diversity and equality of opportunity
- We are committed to building an inclusive and diverse team
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SAS programmingCDISC standardsstatistical programmingdatabase setupreport publishingstatistical conceptsRS-PLUSPythonXML
Soft skills
collaborationcommunicationstrategical thinkingproject managementrelationship buildingmentoringcoachingcritical evaluationrisk managementindependent leadership