[Hiring] Principal Statistical Programmer @Humaneva Group

Role 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.

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.
• 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.

Qualifications

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

Requirements

• Minimum 9-15 years of relevant SAS programming experience for all clinical trial phases and demonstrate the ability to independently perform SAS programming.
• 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.