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Job Details

Senior Programmer - Oncology

Company: Astrazeneca
Location: Cambridgeshire
Reference: R-011576
Closing Date: 28 Aug 17
Type: Permanent
Salary (£): Negotiable
Benefits:

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Job Summary:

At AstraZeneca every one of our employees makes a difference to patient lives everyday. Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people. ...

Requirements:

At AstraZeneca every one of our employees makes a difference to patient lives everyday. Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.



Our Biometrics & Information Sciences (B&I) department is an integral part of Global Medicines Development and drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.



Programming is the department that oversees and delivers the programming aspects of clinical development, manages and maintains the end to end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.

TA Programming is the group that oversees and delivers all the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the TA portfolio of projects. This opportunity is within our Oncology Therapeutic Area.



Successful candidates will be located in Cambridge UK or Gaithersburg, US



Position Focus & Challenge

* Collaborate with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products.

* Collaborate with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to:

* Regulatory response to agency queries
* Development Safety Update Reports (DSUR)
* Periodic Benefit-Risk Evaluation Report (PBRER)
* Investigators brochures (IB)
* Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
* Outcomes studies
* Pharmacokinetics/pharmacodynamics data preparation and analysis
* Manipulating and analyzing adjudicated data
* Delivering Clinical Trial Transparency (data de- identification)
* Data preparation and analysis for Global Medical Affairs work

* Produce and maintain the technical database standards and Programming Specification documents
* Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners

* Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
* Identify opportunities to improve the methodology and provide practical solutions for problems
* Contribute to the development of best practice to improve quality, efficiency and effectiveness



Knowledge, Skills & Experience Required

* BSc in Mathematical, Statistical, Computer Science or Life Science
* Extensive SAS programming experience
* Knowledge of database set-up and report publishing requirements
* Knowledge of technical and regulatory requirements related to the role
* Knowledge of CDSIC standard and industry best pactices
* Experience in clinical drug development or healthcare
* Assist in developing and delivering training
* Values:

* Contributes to innovating and streamlining workflows
* Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area.
* Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation

* Behaviours:

* Team commitment: prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries
* Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team
* Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature
* Communication: agree on how to communicate decisions, successes and escalation of issues etc – speak with one voice instead of separate roles.

* Ability to apply programming expertise to problems, problem solving and quality focus.
* Other programming languages e.g. S-PLUS, R, XML etc.
* Familiarity with Open CDISC Validator



Next Steps -- Apply today!



Please complete the full application on our website and include CV and convering letter detailing your suitaility for the position. If you know someone who would be a great fit, please share this posting with them.



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.

Apply for this job: Senior Programmer - Oncology

Contact Information:

Address:  Cambridge Biomedical
Campus 1 Francis Crick Avenue Cambridge Cambridgeshire
CB2 0AA
England
Website:  Visit Our Web Site

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