Statistical Programmer
2 years ago Banking Hyderabad 283 views Reference: 16566Job Details
Job ID 324690BR
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Contribute to statistical programming activities as Statistical Programmer for phase I to IV clinical studies or project level activities.
• Build and maintain effective working relationship with cross-functional team.
• Review the eCRF, data structures and data review activities. Comply with company, department and industry standards (e.g. CDISC) and processes, create / support the review of programming specifications as part of the analysis plans.
• Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
• Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Minimum requirements
• BE/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 2+ years of work experience in a programming role preferably supporting clinical trials
• Basic SAS experience within a Statistical Programming environment to develop and validate deliverables
• Basic experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Basic understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP)
• Good communications and negotiation skills, ability to work well with others globally
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