Associate Director, Standards Developer

Overview

Lead and manage a team of clinical data standards developers, acting as a technical subject matter expert in clinical data standards for data collection and cleaning components, and driving standards strategy and implementation across the business.

What you'll do

• Lead clinical data standards developers.
• Act as technical subject matter expert in specialised area of clinical data standards data collection and cleaning components.
• Manage activities of CRO partners and external partners.
• Lead quality of own deliverables and oversee quality of other developers' standards deliverables.
• Drive standards development and implementation within the business.
• Contribute to function recruiting, training, and mentoring.
• Demonstrate leadership and operational expertise in the strategic planning and delivery of raw data standards.
• Represent Clinical Data standards at cross functional forums and meetings, and provide timely feedback to partners.
• Contribute to external industry standards and governance groups.
• Provide input to standards strategy and lead the implementation of strategy components to meet the evolving internal and external landscape.
• Lead standards governance and best of industry practices.

What you'll need

• 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 solving.
• 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.

Nice to have

• 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.

Details

• Location: Manyata, Bangalore.
• Work type: Hybrid, with an average minimum of three days per week in the office.
• Role type: Individual Contributor.
• Career level: E.