Associate Director of Statistical Programming
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.
- 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
- 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
- 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.