Lead Statistical Programmer

My name is Manoj Bandi and I represent Synchrony Systems Inc. We are currently supporting an implementation partner on a full-time opportunity. Based on your background your experience may align well with this role.

Location: Addison TX/ Jacksonville FL

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