Senior Statistical Programmer

Advanced Clinical; Ahmedabad District; On-site; INR 300,000 - 550,000; Full time

Job summary

Advanced Clinical in India seeks a Principal Statistical Programmer with expertise in leading statistical programming for clinical trials. The role includes safeguarding CDISC SDTM/ADaM standards, SAS programming, and team mentoring to ensure high-quality outputs.

You will design and validate macros, prepare specifications, and deliver results for complex analyses, integrated summaries and regulatory deliverables. Collaboration across functions is essential.

Qualifications

• Degree in Statistics, Computer Science, or a closely related field; work experience may substitute the 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.

Responsibilities

• Serve as lead programmer on complex clinical trials; or portfolio lead across a large suite of studies for a sponsor.
• 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 SAS programming to generate outputs per the statistical analysis plan (tables, listings, figures, xml/Reviewer’s Guide, integrated summaries).
• Train and mentor others in task execution; monitor scope of work and alert management to changes.
• Develop department training materials and deliver trainings; participate in SOP development and revisions.
• Support business development activities (RFI responses, proposals, industry meetings).
• Participate in candidate interviews and perform other duties as needed.

Skills

SAS programming

Statistical analysis

CDISC standards

Leadership

Communication

Education

Degree in Statistics or Computer Science

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

• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on procedures
  • Participate in the development and revision of department SOPs
• Business Development
  • Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities
  • Assist in the preparation and review of monthly financial reporting
  • Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
  • Participate in candidate interviews
  • Perform other duties as requested by management

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