Statistical Programmer

Parexel International (india) Private Limited; Hyderabad; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Parexel International (india) Private Limited is seeking a Statistical Programmer II in Hyderabad to support clinical trial programming, data listings, and regulatory deliverables. The role focuses on SDTM/ADaM standardization and maintaining documentation in line with SOPs and ICH-GCP guidelines.

We are looking for mid-level professionals with strong SAS skills, good English communication, and the ability to collaborate within a global team and manage multiple priorities in a fast-paced

Qualifications

• Excellent analytical skills.
• Proficiency in SAS.
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and 21 CFR Part 11 regulations.
• Ability to learn new systems in a evolving technical environment.
• Ability to manage competing priorities and flexibility to change.
• Attention to detail.
• Ability to work in a global team.
• Work effectively in a quality-focused environment.
• Effective time management to meet daily metrics/objectives.
• Commitment to high quality work.
• Customer focus and problem solving in operations.

Responsibilities

• Project Management: Assist in coordination of start-up activities, creation of global programs, tracking spreadsheets and required documentation.
• Statistical Programming for assigned projects: Deliver high quality services, produce SDTM/ADaM datasets, tables, figures, and listings, and QC outputs.
• Training: Maintain regulatory knowledge; develop SAS knowledge; mentor staff and project teams as appropriate.
• General: Maintain study documentation per SOPs; ensure compliance with ICH-GCP and regulations; participate in audits and inspections; support process/quality improvements.

Skills

SAS

Analytical skills

Communication skills

Regulatory knowledge

Education

Degree in life sciences / related field

Tools

N/A

Job description

Statistical Programmer II

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities

• Project Management Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
• Statistical Programming for Assigned Projects Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
• Training Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams as appropriate.
• General Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Skills

• Excellent analytical skills.
• Proficiency in SAS.
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Ability to manage competing priorities and flexibility to change.
• Attention to detail.
• Ability to successfully work as part of a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.

Knowledge and Experience

• Competent in written and oral English.
• Good communication skills.

Education

Educated to degree level in a relevant discipline and/or equivalent work experience.

Experience Level

Mid Level