Associate Director, Statistical Programming

Company Description

Agati Clinical is a fast-growing global life sciences services company with a robust portfolio of solutions and services. Specializing in customized clinical staffing solutions and specialized clinical data services, Agati focuses on Data Management, Data Standardization (CDISC), Biostatistics, Statistical Programming, and Regulatory Services. Serving pharmaceutical, biotechnology, and medical device companies, we support all phases of clinical development to ensure success and compliance.

Role Description

Associate Director, Statistical Programming coordinate and act as a statistical programming subject matter expert for any phase of clinical trial study and/or review of programming deliverables. Provide inputs on effort estimates, review of RFPs, prepare proposal text and attend bid defence meetings as required. Oversee programming team activities, provide technical and project specific guidance to team members, responsible for resource planning/allocation, operational management, recruitment, mentoring subordinates. 

Role and 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

Education:

• Any bachelor’s or master's degree, preferably in computer science, engineering, mathematics, statistics or life science

Experience:

• Minimum 15-18 years of relevant SAS programming experience for all clinical trial phases and demonstrate the ability to independently perform SAS programming

Location:

• Chennai (Or) Bangalore

Skills:

• Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies
• Proven leadership skills and the ability to lead the statistical programming group by example
• Strong ability to understand and assess technological and procedural alternatives and the implication of change on current processes
• Must have strong work ethics and be able to work independently and productively
• Ability to lead and motivate a team
• Ability to manage quality and timely customer expectations
• Excellent communication, organisational, problem-solving skills