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Principal Statistical Programmer

Advanced Clinical -
Ahmedabad, Gujarat

Quick apply

Job details

Full-time
10 hours ago

Qualifications

Statistics
Computer Science
XML
SAS
Clinical experience
Macros
Clinical trials
Medical terminology
Communication skills

Full 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

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.

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