COMPANY DESCRIPTION
Agati Clinical is a rapidly expanding global life sciences services company with a comprehensive portfolio of tailored solutions and services. The organization specializes in providing clinical staffing and advanced clinical data services, including data management, data standardization (CDISC), biostatistics, statistical programming, and regulatory services. Agati Clinical supports pharmaceutical, biotechnology, and medical device companies across all stages of clinical development. The company is committed to delivering solutions that meet the unique needs of its clients in the rapidly evolving life sciences industry.
GENERAL DESCRIPTION
Principal Statistical Programmer-I coordinate and act as a statistical subject matter expert for any phase of clinical trial study and/or review of programming deliverables. Ensure all work is processed on time with best quality, oversee programming team activities and provide technical and project specific guidance to team members. Act as programming team lead for multiple moderate-complex studies.
ROLES AND RESPONSIBILITES
Primary Responsibilities Include:
- 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 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
- Responsible for initiation of protocol and SAP discussion and actively participate in the discussion.
- Develop and/or validate specification, programming for CDISC Data Standards, TFL programming for multiple 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
- To 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
- 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
- Assist in audit specific requirements for internal or external audits and contribute towards quality and process improvement initiatives
- Perform other duties as assigned by Department Head or Immediate Supervisor
REQUIREMENTS
Education:
- Any bachelor's or master's degree, preferably in computer science, engineering, mathematics, statistics or life science
Experience:
- Minimum 8+ years of relevant SAS programming experience for all clinical trial phases and demonstrate the ability to independently perform SAS programming
Skills:
- Good working knowledge in all phases of clinical trials
- Exposure in working in various therapeutic areas
- Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies
- Excellent verbal and written communication skills
