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Lieu: Gaithersburg, Maryland, États-Unis Cambridge, Angleterre, Royaume-Uni
ID de l'offre 10724296
Date de publication: 09/16/2019

Statistical Programmers - Senior / Principal -  Oncology / Respiratory / CVRM

Location(s) – Cambridge (UK), Gothenburg (Sweden) or Gaithersburg (US); Permanent

Salary - Competitive salary and company benefits apply

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.

As a Senior or Principal Programmer, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.

The new R&D BioPharmaceuticals organisation brings together research and development teams, from discovery through to late-stage development for Cardiovascular, Renal & Metabolic (CVRM), Respiratory, Inflammatory and Autoimmune (RIA) therapy areas, and opportunistically for Microbial Sciences and Neuroscience.

The new R&D Oncology organisation brings together early and late oncology teams, from discovery through to late-stage development, with oncology specific Regulatory and Biometrics groups.

Role

You will provide Statistical Programming support and/or lead all programming related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialisation and the scientific utilisation 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.

You’ll 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, you’ll be an experienced programmer with good knowledge of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You’ll 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.

We have several opportunities across both Senior and Principal levels.

Desirable experience includes:

Both

  • BSc in a Mathematical (i.e. 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

Senior

  • SAS programming expertise gained within a clinical drug development or healthcare setting
  • Knowledge of CDSIC standards and industry best practices
  • Knowledge of database set-up and report publishing requirements

Principal

  • 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

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete your application on our website at your earliest convenience.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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.

Date job advert open: 16th September 2019

Closing date for applications is: 16th October 2019

Statistical Programmers - Senior / Principal - Oncology / Respiratory / CVRM
Développement clinique

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