Senior Statistical Programmer

Advanced Clinical; Ahmedabad District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Advanced Clinical is seeking a Principal Statistical Programmer with a strong background in SAS and regulatory data standards to lead programming for complex clinical trials. The role combines technical coding with study-level leadership and mentorship.

The candidate will design, develop and validate SDTM/ADaM datasets, tables, listings and figures according to the SAP, and coordinate with cross-functional teams to ensure timely, high-quality outputs across sponsor studies.

Qualifications

• Degree in Statistics, Computer Science, or closely related field (or equivalent experience).
• Minimum 6 years direct SAS programming experience in pharmaceutical development or CRO environment.
• Knowledge of CDISC SDTM/ADaM and regulatory standards.
• Excellent communication, organization and attention to detail.

Responsibilities

• Exceed expectations of Senior Statistical Programmer.
• Lead programming on complex trials or portfolio across studies.
• Coordinate and ensure accuracy of activities for support programmers.

Skills

CDISC SDTM/ADaM

SAS programming

Clinical trials

Regulatory standards

Leadership

Education

Degree in Statistics/CS or related field

Tools

SAS

Job description

The Principal Statistical Programmer ("Programmer") will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials.

Responsibilities

• Exceed expectations and responsibilities of a Senior Statistical Programmer
• Understand and implement CDISC and other regulatory standards
• Follow internal SAS programming conventions
• Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
• Coordinate and ensure the accuracy and completeness of activities for assigned support programmers
• Create and maintain project timelines
• Design, develop, document and validate tools and macros to improve quality and efficiency of processes
• Prepare and review programming specifications for SDTM, ADaM and other derived datasets
• Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
• Analysis datasets (SDTM, ADaM, other derived datasets)
• Tables, listings and figures
• xml/Reviewer’s Guide
• Integrated summaries
• Perform ad hoc analyses of current and legacy databases
• Review and provide input on case report form design
• Serve as a subject matter expert
• Train and mentor others in task execution
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
• Develop department training materials and deliver trainings to the team
• Drive/facilitate/actively engage in department initiatives
• Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs

Qualifications:

• The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree
• Minimum of 6 years direct SAS programming experience in pharmaceutical development or CRO environment
• Good knowledge of medical terminology and conduct and analysis of clinical trials
• Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.)
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Company Description:

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.