Job Description:

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.
• Strong 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 robust project management skills to coordinate tasks and resources
effectively.

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