Associate Director, Statistical Programming.

Role & responsibilities:

• Promote and adhere to the values of the organization, Integrity, Innovative to Differentiate, Dependable and Trusted Partner, Quality on Time and Grow Collectively
• Manage or lead multiple project assignments and programming team by acting as point of contact with the Project Management and sponsor team to ensure smooth coordination of the projects
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies
• Develop and/or validate specification, programming for CDISC Data Standards, TFL programming for complex studies
• Develop and manage metrics on a periodic basis to enable sufficient and consistent feedback and identify improvement areas and create a training plan as required
• Identify changes to the approved project plan and manage through a change control process which reviews impact on timelines, budget and resources
• Provide inputs on baseline estimations, new business proposals and project plans as required
• Produce accurate resourcing plans in conjunction with assigned Project Team Members
• Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
• Timely completion of client specific and organization specific training documentation
• Workload forecast for the team and provide a vision of the ongoing project objectives or milestones and provide clarity on the upcoming projects
• Assist in the development and maintenance of the SAS programs/macros, templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data
• Provide mentorship for associates working on the project and support training requirements for the trainees or team members
• Involve in process improvement activities to improve the current processes and achieve efficiency and enable the processes are in line with the Regulatory/Industry requirements
• Setting up challenging, achievable goals for associates which contribute to department objectives and support efforts to achieve those goals
• Provide timely performance feedback to associates on a routine basis as well as during Annual performance review
• Supervision on project status, budget expenditures on regular basis, identify any problem and recommend solution.