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Role: Clinical Statistical Programmer

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Location : Hyderabad, Bengaluru, Pune, Chennai, Delhi NCR

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Mode of work : Onsite (5 days a week)

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Educational Qualification / Experience for the role:

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Master's degree with 6+ years of experience or bachelor's degree with 8+ years of experience in statistics, computer science, engineering, or a related field

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Required Skillsets:

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• Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
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• Proficiency in using statistical software and programming tools
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• Understanding of statistical methods, data analysis techniques, and clinical research processes.
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• Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
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• In-depth understating of drug development process and clinical study life cycle
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• Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
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• Strong experience in generating TLFs, programming macros, and data manipulation using SAS.
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• Good to have experience in other statistical programming languages (R).
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• Experience working on cross-study, integrated data analysis.
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• Strong attention to detail and quality Focus
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• Problem-solving skills (Ability to identify and troubleshoot programming issues)
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• Effective communication skills (both written and verbal)
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• Ability to interact professionally with statisticians, study teams, and external partners
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• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.
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Key Responsibilities:

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• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
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• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
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• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
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• Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
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• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
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• Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
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• Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
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• Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
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• Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
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• Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.
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• Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality.
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• Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk.
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• Coach/Mentor/Train new team members and line function as per requirement.
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