Statistical Programmer at Senior or Principal level
AstraZeneca Göteborg / Marknadsföringsjobb / Mölndal
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hela Sverige AstraZeneca's Biometrics & Information Sciences is seeking an experienced and independent Statistical Programmer at Senior or Principal level.
Your experience and skills are genuinely valued and you will be part of every stage of the information to action cycle (design - analyse - interpret - decide - submit - response - expand)
Location: Gothenburg, Sweden or Cambridge, UK.
Core Accountability & Responsibilities (will vary based on career level Senior or Principal)
Strong Technical Expertise:
• Responsible for delivery of the technical components required to support the analysis and reporting for a project.
• Expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment.
Strategic Leadership:
• Provide strategic input and leadership to the delivery of all statistical programming and information components of a project.
• Working as a member of a TA-aligned and quality-focused global programming team.
• Continually build and managing relationships to create the conditions of success for our global project teams in order to support decision-making.
• Work as part of our GMD (Global Medicines Development) business unit. GMD progresses products through late-stage development, registration, and ongoing post-launch development activities.
• Deliver a strong understanding of drug development process to support the full project lifecycle
Successful Collaboration:
• Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of databases by these partners.
• Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverables.
Effective Regulation & Compliance:
• Leading programming contributions to data integration strategies, regulatory submissions, and timely responses to regulatory questions.
• Produce and maintain the technical database standards and Programming Specification documents
Your Experience and Education:
• Statistical programming or other relevant functional-area experience in a Phase IIb/III environment. Ability to apply this expertise to a range of challenges, deliver effective solutions and ensure a quality focus.
• Your technical expertise will evidence SAS programming at high level.
• Expert knowledge of CDISC standards (CDASH, SDTM, ADaM) and their application
• Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
• If at Principal level, ability to take a leadership role in all statistical programming activities for a clinical project including supervising the work of junior programmers.
• Interpersonal skills and problem-solving capabilities with the ability to work independently under minimal supervision.
• Experience in managing external vendors and working with industry partners, to work across global & functional boundaries.
• Experience with global regulatory submissions and knowledge of GCP and applicable technical/regulatory requirements.
• Therapeutic area expertise: Preferably in Respiratory or Inflammation
Education: Your career will be built on a BSc or post graduate qualification (or local equivalent) in Mathematics, Statistics, Informatics, Life or Social Sciences
Biometrics and Information Sciences at AstraZeneca - From data to decisions....we make sense.
Biometrics & Information Sciences (B&I) is the home of late stage development biometrics activity at AstraZeneca. B&I drive good design to generate the data needed for quality decision making on AstraZeneca's late stage Projects. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the...... TO READ FULL JOB DESCRIPTION AND APPLY PLEASE VISIT WWW.ASTRAZENECA.COM
More than ever, science is accelerating our rate of understanding in a wide range of medical fields - and that's only set to increase. As a global, science-led biopharmaceutical business, AstraZeneca is at the forefront of that evolution. That means an unparalleled product portfolio and a strong pipeline across all stages of the drug development process. Everything we do comes back to improving the health of our patients worldwide, and to make that happen we're focusing on some of the most challenging diseases facing humanity today.
We have a highly collaborative culture, where you'll be encouraged to push the boundaries of science while developing industry-recognised skills and experiences.
Publiceringsdatum2017-04-05Så ansöker duSista dag att ansöka är 2017-04-24
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Pepparedsleden 1
43183 MÖLNDAL
KontorsadressPepparedsleden 1
Jobbnummer 3420060
Observera att sista ansökningsdag har passerat.