Associate Director - Clinical Data Standards

Astrazeneca India Private Limited; Bengaluru; Hybrid; INR 4,200,000 - 6,000,000; Full time

Job summary

AstraZeneca is seeking an Associate Director, Clinical Standards in Bengaluru (Manyata) on a hybrid basis. You will lead a team of clinical data standards developers, drive governance, and mentor staff across cross-functional projects to deliver high-quality data standards in raw data collection and cleaning.

Strong leadership, project management, and communication are essential as you collaborate with CROs and internal teams to advance standards strategy and execution.

Qualifications

• BSc or MSc in Information Sciences, Math, Stats, CS or Life Science.
• Expertise in standards development: raw data standards, data cleaning components, SDTM/ADaM, or Biometrics functions.
• Excellent knowledge of industry standards (CDASH, SDTM).
• Strong communication skills in English, both written and spoken.
• Strong project management skills and ability to mentor teams.

Responsibilities

• Leads clinical data standards developers and manages cross-functional projects.
• Acts as a SME in data standards for data collection and cleaning components.
• Oversees CRO and external partner activities and deliverables.
• Drives governance and best practices for standards development and implementation.
• Mentors staff and contributes to recruiting and training.
• Represents standards in cross-functional forums and feedback with partners.

Skills

Clinical data standards

Leadership

Communication

Project management

Mentoring

Education

BSc or MSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science

Tools

SAS

R

Python

Spotfire

Java

C/C++

Job description

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

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 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

Join an organization passionate about science, data, and technology to drive meaningful breakthroughs for patients. You will work shoulder to shoulder with clinicians, biostatisticians, operations specialists, and data scientists—often around the same table—turning ambitious questions into concrete study plans and decisive results. Here, curiosity is encouraged, informed risk-taking is supported, and learning is continuous, backed by a strong pipeline and real-world impact. We bring diverse minds together from industry and academia, pair ambition with kindness, and give you the tools and empowerment to explore, experiment, and deliver data that shape the future of medicine.

Diversity and Inclusion

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.