Job Description

Job Title: Senior Specialist, PKPD / Pharmacometric Data ProgrammerCareer Level - DIntroduction to role
Are you ready to make a significant impact in the world of drug development? We are seeking a Senior Specialist Programmer for PKPD / Pharmacometric Data Programming. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study levels. You will be instrumental in influencing critical decision making throughout all phases of drug development and regulatory interactions.Accountabilities
As a Senior Specialist Programmer, you will be accountable for expert data integration, manipulation, and preparation results at the study level. You will execute state-of-the-art data preparation techniques with direct value for the study. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations.Essential Skills/Experience:

• Proficient oral and written English communication skills
• Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM, Monolix, R, Matlab)
• Strong SAS/R programming skills
• Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM)
• Demonstrated data programming and clinical development expertise
• Good knowledge of global regulatory, compliance, processes, standards
• Bachelor\xe2\x80\x99s degree MS preferred with 1 to 3 years relevant experience required
• Varied programming languages (SAS, R, Python)
• Experience in early and late-stage drug development
• Quantitative/Scientific background (Statistics, Engineering, Biological Science)

• Scientific publishing in the field on pharmacometrics
• Knowledge in pharmacology, drug targets and core Therapy areas (e.g. Oncology, Respiratory, Renal Metabolism etc.)
• Relevant regulatory experience

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\'s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\'re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca\'s Biopharmaceuticals R&D division, we are unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world\'s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our shared belief in what science can do - a belief in its potential to redefine what\'s possible.Are you ready to join a team that makes a bigger impact on patients\' lives? If your passion is science and you want to be part of a team that makes a bigger impact on patients\' lives, then there\'s no better place to be. Apply now!Date Posted 24-Oct-2024Closing Date 31-Oct-2024AstraZeneca 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.

AstraZeneca