Academic / Professional Qualification / Working Experience

• BSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience
• Advanced SAS programming knowledge
• 5+ years of working experience in Pharmaceutical industry

Technical / Skills Training

• Proficient knowledge of CDSIC standard and industry best practices
• In-depth Knowledge of database set-up 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, eg. Oncology
• 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

DUTIES & RESPONSIBILITES

Key Tasks

•     Collaboration with AZ Global Product Programmer and other 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 TFL templates, validation plans and quality documentation, SDTM 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

•     Accuracy of database structures, values and algorithms;

•     Adherence to analysis and standards requirements for study databases and TFLs

•     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

Date Posted

17-6月-2020

Closing Date

31-7月-2020

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.