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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.ResponsibilitiesProject Responsibilities
Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with BDS’s software development lifecycle procedures
Provides comprehensive programming leadership and support to clinical development teams
Ensures quality of BDS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
Drives the development and implementation of innovative strategies and technologies for clinical trial programming
Develops unambiguous and robust programming specifications for internal and external programming work
Provides technical guidance to statistical programmers and vendors around project conventions, standards, practices, and specifications to ensure integrated computing solutions
Reviews planning documents (e.g. statistical analysis plans, data presentation plans, data review plans) to ensure clarity, integrity and compliance with requirements and standards
Managerial Responsibilities
Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains 3-5 direct reports, resulting in an increasing level of capabilities within BDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with the Director of Statistical Programming of ICF
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with Director of Statistical Programming of ICF regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results.
Models acceptable behaviors and communication with stakeholders to ensure effective partnerships
Serves as a point of escalation for technical, operational and staffing issues which are unable to be resolved at the team level
Enables a culture of inclusiveness, respect for diversity, compliance with processes; encourages the questioning and challenging of others in a respectful and constructive manner
Identifies, leads, and supports improvement initiatives within BDS and serves as a BDS representative on cross-functional initiatives
Qualifications
Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
Minimum of 10 years of clinical/statistical programming experience within pharmaceutical clinical development with experience that includes leading programming efforts to support regulatory filings (e.g. US, EU, Japan)
Minimum 5 years of experience in managing technical professionals in a regulated environment
Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing techniques in addition to knowledge of R or other statistical software packages
Significant knowledge of the drug development process, clinical trial methodology, statistics and relevant regulatory requirements for drug approval
Demonstrated ability to operate and lead in a matrix organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.
Able to adapt quickly to the changing needs of the organization
Able to organize multiple work assignments and establish priorities
Excellent verbal and written communications skills; able to communicate proactively and effectively
US military experience shall be considered towards industry and professional experience requirements.Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.