Lead statistical Analyst

Job description

Role

Lead statistical Analyst /Lead Statistical Programmer/Manager, Statistical Programming 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/inidication.
• 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. <span lang="IT" style="font-family:"Aptos"

Qualifications

BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), MASTER OF PHARMACY, MASTER OF STATISTICS