• United States Of America, Usa

Job Description:

Principal Statistical Programmer Oncology

Location Gaithersburg (US)

Would you like to be a part of a Programming group who has direct strategic impact on drug development, playing a key role in getting medicines to patients

At AstraZeneca every one of our employees makes a difference to patient lives every day We are building on our strong pipeline and turning ideas into life-changing medicines that benefit patients around the globe

Within AstraZeneca our Programming group sits within our Biometrics & Information Sciences (B&I) department, which drives good design to generate the data needed for quality decision making on our projects B&I is an integral part of our Global Medicines Development (GMD) division, the area of our business responsible for late stage drug development transforming innovative science to medicines

Role

You will provide Statistical Programming lead related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialization and the scientific utilization of our data for AstraZeneca products There are many career options you can pursue for progression including technical pathways, management of global projects or line management

You will work in the Programming department that not only oversees and delivers the programming aspects of analysis and reporting but also manages and maintains our end to end standards and our analysis and reporting production tools

Youll be part of a global team that pulls together to put patients first

Responsibilities

Reporting to an Associate Director/Director within the Statistical Programming group you will provide programming expertise in one or more of the following areas

Lead/Contribute to the delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models
Lead/Contribute to the statistical programming deliverables for regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
Produce and maintain technical database standards and programming specification documents
Lead/Contribute to the development of best practice to improve quality, efficiency and effectiveness
Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
Planning and executing the transfer and analysis of data for safety/efficacy monitoring boards/independent data monitoring committees

Requirements

To succeed in this role, youll be an experienced programmer with good knowledge of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry Youll enjoy multitasking, collaborating as part of a global team, and have an appetite for solving problems You will be an effective communicator, with a strong team focus who enjoys collaborating to achieve the best results

Requirements

Bachelors Degree in a Statistical or Mathematical (ie Applied Math, Engineering, etc), Statistical, Computer Science or Life Science subject

Excellent problem-solving skills

Diligence attention to detail and ability to manage concurrent projects and activities

Excellent verbal and written communication skills and ability to influence stakeholders

Extensive SAS programming expertise to an advanced level gained within a clinical drug development or healthcare environment

Comprehensive knowledge of technical and regulatory requirements with submission experience

Wide-ranging knowledge of CDSIC standards and industry best practices

Travel willingness and ability to travel domestically and/or internationally

Team centric approach keen to take steps to understand and appreciate the roles, skills and strengths of others on the team

Principal Statistical Programming

Clinical Development

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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