Manager - Statistical Programming (Hybrid)

Responsibilities

• Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
• 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.
• Safeguards consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Develops and oversees 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.

Qualifications

• Minimum Job Qualifications: Bachelors in Statistics or Mathematics, 10+ years of relevant experience (or 8+ with a Masters).
• Previous experience leading a team/project of statistical programmers.
• Experience with SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• Experience with ADaM development and TLF generation is required.

Preferred Qualifications

• Experience with regulatory filings.

Additional Information

• Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.
• The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.