Bristol-Myers Squibb Company

Statistical Programming Technical Manager

Location
Princeton, NJ
Posted
May 29, 2019
Ref
R1515702
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary

The Global Biometric Sciences (GBS) Statistical Programming Technical Manager provides functional expertise and leadership to Statistical Programming and Data Science (SP&DS) colleagues while delivering comprehensive programming expertise to clinical project teams in support of development, regulatory approval, and market acceptance of Bristol-Myers Squibb (BMS) products. This position is primarily responsible for the designing, developing and implementing technical solutions for integrating, analyzing and reporting clinical data. Includes using SAS, R, and other statistical software packages.

Responsibilities

Ensures quality of GBS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices

Provides comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, corporate and departmental SOPs and work practices

Drives the development and implementation of innovative strategies and technologies for clinical trial programming

Provides technical guidance to vendors around project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project computing strategies

Reviews planning documents (e.g. statistical analysis plans, data presentation plans, data review plans) to ensure alignment with development team objectives. These reviews focus on clarity, integrity and completeness of programming assumptions and requirements, and ensure compliance with standards

Develops unambiguous and robust programming specifications for internal and external programming work

Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and BMS standards

Understands software development methodologies and appropriately applies those methodologies

Identifies opportunities for increased efficiency and consistency within GBS and provides leadership and support to improvement initiatives.

Qualifications

Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience

Minimum of 6 years clinical/statistical programming experience within pharmaceutical clinical development

Extensive knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements (e.g. CDISC, electronic data package submissions, SCS)

Broad expertise in statistical programming and developing computing strategies for statistical analysis & reporting within the pharmaceutical industry

Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) R and general computing technics

Ability to work successfully within cross-functional teams leading by developing and maintaining successful partnerships

Demonstrated ability to flexible and adapt quickly to changing needs within an organization

Demonstrated ability to organize multiple work assignments and establish priorities

Communicates proactively and effectively; excellent verbal and written communications skills

US military experience will be considered towards industry and professional experience requirements