Associate Director, Standards Developer

Overview

Lead and manage a team of clinical data standards developers, acting as the subject matter expert for raw data collection and cleaning components and driving standards development and governance 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.
• Career level: E. Role type: Individual Contributor.
• Experience: 8 to 15 years.