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Essential Functions

- Develops and validates complex datasets and outputs using SAS programming,

ensuring compliance with CDISC standards such as ADaM and SDTM models.

- Performs Safety and/or Efficacy analysis programming, including creation of efficacy datasets and efficacy outputs (Tables, Listings, and Figures).
- Authors and reviews ADaM specifications for Safety and/or Efficacy analyses in compliance with CDISC standards.
- Creates and maintains regulatory submission documentation including Analysis Data

Reviewer’s Guide (ADRG) and Define.xml.

- Utilizes Pinnacle 21 (P21) to validate datasets and ensure submission readiness and compliance with regulatory requirements.
- Collaborates with cross-functional teams to optimize statistical programming processes and enhance overall efficiency and accuracy.
- Provides technical guidance and expertise on statistical methodologies to support clinical trial projects and departments.
- Mentors and guides junior programmers, fostering their growth and development.
- Contributes to the continuous improvement of programming workflows and departmental standards.
- Ensures high-quality deliverables from the statistical programming department by adhering to best practices and established protocols.
- Leads initiatives to enhance programming tools and techniques, driving innovation in statistical programming.
- Partners with leadership to align programming objectives with larger organizational goals.
- Utilizes R programming to support statistical analyses, automation, data manipulation,

reporting,



and development of programming solutions where applicable.

- Minimum 1 year of hands-on R programming experience is mandatory.
- Experience in Safety OR Efficacy analysis programming is required.
- Hands-on experience in creation of efficacy datasets and efficacy outputs (Tables,

Listings, and Figures).

- Experience in ADaM specifications writing for Safety and/or Efficacy studies.
- Experience in creating Analysis Data Reviewer’s Guide (ADRG), Define.xml, and performing dataset validation using Pinnacle 21 (P21)

Qualifications

- Bachelor's Degree Statistics, Computer Science or related field Req
- Master's Degree Statistics or Computer Science Pref.
- Robust knowledge of CDISC SDTM and ADaM standards.
- Ability to lead/manage others Capably leads and manages programming teams,

ensuring adherence to standards and mentoring junior programmers.

- Demonstrated ability to maintain confidential information Maintains strict confidentiality of sensitive project data and internal communications.
- Demonstrates excellent judgment and decision-making skills Exercises sound judgment and decision-making in selecting statistical methods and programming techniques.
- Ability to work within tight timeframes and meet strict deadlines Effectively manages time and resources to deliver high-quality programming outputs within tight deadlines.
- Project Demonstrated project management skills Executes projects efficiently,

demonstrating strong project management skills to coordinate tasks and resources effectively.

📌 IQVIA/ Statistical Position / India
🏢 Acura Solution
📍 India