Lead Statistical Programming Manager

BioSpace; Florham Park (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie seeks a Manager of Statistical Programming to guide a team of programmers in the early development of new pharmaceutical products. The role interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations to ensure robust programming support for ADaM data sets and Tables, Listings, and Figures.

You will mentor staff, ensure timely deliverables, and uphold quality standards across projects while developing standard macros and SOPs to support

Qualifications

• MS in Statistics, Computer Science or a related field with 8+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience.
• Previous experience leading a team of statistical programmers.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• 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.
• Ability to accurately estimate effort required for project related programming activities.

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.
• 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.

Skills

Leadership

SAS

CDISC Standards

Drug development

Communication

Cross-functional

Mentoring

Education

MS in Statistics or CS

BS in Statistics or CS

Tools

SAS

Job description

AbbVie seeks a Manager of Statistical Programming to guide a team of programmers in the early development of new pharmaceutical products. The role interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations to ensure robust programming support for ADaM data sets and Tables, Listings, and Figures.

You will mentor staff, ensure timely deliverables, and uphold quality standards across projects while developing standard macros and SOPs to support