Associate Director, Clinical Standards

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About the role

Job Title: Associate Director, Clinical Standards • Global Career Level: E • Role Type: Individual Contributor • Location: Manyata, Bangalore • Work Type: Hybrid • Experience: 8 to 15 years About AstraZeneca AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. Introduction to role: The Associate Director Clinical Standards is accountable for leading, managing and developing a team of clinical data standards developers. They present a department mindset and management skills to run and oversee scope and complexity of clinical data standards in raw data collection and cleaning components packages. As a recognized expert within their own field they are often the first point of contact for related queries, acts as a coach or mentor for staff, and acts as a specialist within cross-functional teams to deliver continuous improvement. The Associate Director Standards Developer can be responsible for leading cross functional projects and/or initiatives within standards and may manage external partner relationships or initiatives. Accountabilities: • Leads clinical data standards developers • Technical subject matter expert in specialised area of clinical data standards data collection and cleaning components • Manages activities of our CRO partners and external partners • Leads quality of own deliverables and oversees quality of other developers standards deliverables • Drives standards development and implementation within the business • Contributes to function recruiting, training, and mentoring • Demonstrates leadership and operational expertise in the strategic planning and delivery of raw data standards • Represents Clinical Data standards at cross functional forums, meetings and provides timely feedback to partners. • Can contributes to external industry standards and governance groups • Provides input to standards strategy and leads the implementation of strategy components to meet the evolving internal and external landscape • Leads standards governance and best of industry practices Essential Skills/Experience: • BSc or MSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science. • Expertise in specialised standards development skills (eg, raw data standards with data collection and cleaning components, clinical coding dictionaries, and data analysis & reporting standards (SDTM, ADaM, TFLs)) or expertise in Biometrics functions (eg, Data Management, Programming, or Statistics) • Excellent knowledge of industry standards (eg, CDASH, SDTM) • Ability to apply standards expertise to problem • Excellent communication skills in both written and spoken English • Strong project management skills • Ability to mentor, train and lead teams • Thorough knowledge of the clinical development process • A clear demonstration of behaviours of truth seeking rather than success seeking Agile responsiveness to industry and business needs Embracing of peer review Desirable Skills/Experience: • Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl) • Ability to influence relevant stakeholders on standards related items • Ability to manage risk 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 t

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