Statistical Programmer
2 days ago
Role: Statistical Programmer
Job Code: 357890
Band: BPO 4/5/6 for locations: Mumbai/Pune/Bangalore
Salary Range: LPA
Shift: General Shift
Location: Mumbai/Pune/Bangalore
**CV must be rejected if candidate is not in Mumbai / Pune / Bangalore**
Preferred Educational Qualification for the role: Life science graduate / Computer science graduate/ Statistical graduate
Preferred experience for the role: Minimum 2+ years of experience in SAS programming
Reporting to (Role): Delivery Manager
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 in drug development process and clinical study life cycle
• Good to have experience in other statistical programming languages (R).
• In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience Etc.)
• Experience with regulatory filings.
• Effective communication skills (both written and verbal)
• 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 a compound/indication.
• Leads a team of statistical programmers and manages the resource planning for assigned staff.
• 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 sets following CDISC standards.
• Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• Ensures consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.
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