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Position: Senior Statistical Programmer
Experience: 10 to 15 years
Location: Trivandrum
Required Skillsets:
• Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
• Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
• In-depth understanding of SAS programming concepts and techniques related to drug development and clinical study life cycle.
• In-depth understanding of CDISC Standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.).
• In-depth understanding of the drug development process,
including experience with regulatory filings.
• Ability to communicate clearly both oral and written.
• Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
• Ability to accurately estimate effort required for project related programming activities.
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines
Key Responsibilities:
• Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
• Manages a team of statistical programmers and the resource planning for their assigned projects.
• Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• Develops and oversees the development of SAS programs for the creation of ADaM data