Job Title: Director, CPQP Data Programming
Career Level - F
Introduction to Role:
We are seeking a Director for PKPD Pharmacometric Data Programming to provide technical leadership and influence consistent approaches to data integration. This role is pivotal in preparing complex data to support translational modelling, population PK, PKPD, exposure-response, and disease modelling, and simulations in all clinical development phases. The CPQP Programming Director will be responsible for the design, implementation, maintenance and communication of technical solutions with pharmacometric programming. This role is an opportunity to apply state-of-the-art Pharmacometric Modeling and Simulation (M&S) data preparation approaches to influence designs and internal/external decision making at the project level.
Accountabilities:
As the Director, you will lead, develop and mentor a group of Programmers. You will use your project management skills to lead pharmacometric programming deliverables to support regulatory submissions. You will oversee the quality of all deliverables and hold partners accountable for their deliverable quality. You will also contribute to the development of best practices to improve quality, efficiency and effectiveness. You will be responsible for integrating internal (and external) data to support interpretation and decision making at the project level.
Essential Skills/Experience:
- 10+ years of industry experience with solid project management and delivery experience
- Demonstrated leadership capabilities
- Extensive SAS programming expertise to an advanced level
- Experience with pharmacometric or pharmacokinetic data and practices
- Comprehensive knowledge of technical and regulatory requirements related to the role
- Knowledge of CDASH/SDTM/ADaM CDISC standards
- Experience of regulatory submissions
- Demonstrated managerial experience
- Domonstraated ability to drive cross-functional infrastructure improvements
- Excellent communication skills
- Excellent collaboration required – needs the energy to work across global & functional boundaries
- Ability to apply programming expertise to problems, problem solving and quality focus
- Excellent knowledge in pharmacology, drug targets and core Therapy areas (e.g. Oncology, Respiratory, Renal Metabolism etc.)
- Varied programming languages (SAS, R, Python)
- Exposure to modelling tools– NONMEM, Stan, Monolix, etc
- Bachelor’s degree
- Preferred MS or PhD in Mathematical, Statistical, Computer Science or Life Science
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 Business Unit, we are rethinking the way things can be done and acting on it. We go above and beyond to find solutions that impact patients - harnessing science with technology and connecting the entire healthcare ecosystem. It's our patients that come first, every decision we make and action we take is centred around how we can better serve them. We strive to create a place where everyone is empowered to speak up and share ideas, and we welcome alternative perspectives to push our thinking further, together.
Are you ready to fuel your ambition and break new ground? Join us in shaping patient care for the future! Apply now!
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AstraZeneca 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.