JOB REQUIREMENTS:

Academic / Professional Qualification / Working Experience

* 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

Technical / Skills Training

*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

Key Tasks

*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 ho 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

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

Date Posted

Closing Date

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.