Associate Director, Clinical Standards
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
Introduction to role
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 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.
Why AstraZeneca
Call to Action
Date Posted
Closing Date
Not included in the source posting: what you'll do, benefits.
Skills
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