Senior Manager-Statistical Programming

Job description

Role

Senior Lead statistical Analyst / Senior Lead Statistical Programmer/ Senior Manager, Statistical Programming Educational Qualification / Experience for the role: MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Minimum of 2 years' experience leading a team of statistical programmers.

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 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. 7.<span style="font-style: normal; font-variant: normal; font-size-adjust: none; font-language-override: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variati

Qualifications

BACHELOR OF SCIENCE ( B.Sc Degree ), BACHELOR OF STATISTICS, M.SC., MASTER OF STATISTICS