Associate Director of Statistical Programming - SDTM amp Standards

Profile

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.

The Biometrics & Data Sciences (BDS) Associate Director of Statistical Programming -SDTM & Standards provides expertise with Clinical Data Interchange Standards Consortium (CDISC) standards, and electronic data package submissions as well as leadership to statistical programming colleagues in BDS and external partners (EP). This position is responsible for designing, developing and implementing technical solutions and standards for integrating, analyzing, reporting and submitting clinical data to support drug development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. The candidate will also play a leadership role in the implementation of a new Statistical Computing Environment. This role reports to the Senior Director of Statistical Programming - SDTM & Standards and may have direct supervisory responsibilities for as many as 5 Statistical Programmers in future consideration.

Responsibilities


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

Develops unambiguous and robust global programming specifications for internal and external programming work with a focus on clarity, integrity and completeness of programming assumptions and requirements

Provides technical guidance to statistical programmers and vendors around BDS conventions, standards, practices, and specifications to ensure integrated computing solutions

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

Develops, troubleshoots, and maintains complex programs and utilities

Draws on experience with identification of challenges, inefficiencies or downstream impacts, identifying solutions, engagement of appropriate stakeholders, garnering of management support, and implementation of a roll out plan (i.e. procedural documents, training materials, and training) to minimize risk and maximize quality.

Represents BDS positively through effective stakeholder and study team engagement

Identifies opportunities for increased efficiency and consistency within BDS and provide leadership and support to improvement initiatives. Provide expertise to development teams with regard to driving standardization and formulating solutions to complex issue.

Plays a leadership role on cross-functional initiatives and capital projects as a BDS representative providing business input into system/user requirements, risk assessments, process document authoring, validation script writing, execution, and approval, as well as development of training materials, providing status updates, and other duties.

Lead or participate in the development of departmental standard operating procedures, working procedures and guidance documents


Managerial Responsibilities (when applicable)


Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains as many as 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 Senior Director of Statistical Programming - SDTM & Standards

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 Senior Director of Statistical Programming - SDTM & Standards 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 process and allows for the questioning and challenging of others in a respectful and constructive manner


Qualifications


Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology 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)

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

Experience leading a large cross-functional initiative, or (at minimum) a work stream within a capital project

Thorough knowledge in CDISC standards (both SDTM & ADaM) and hands on experiences of leading all types of SDTM (ADaM) domains design, development and validation.

Expertise with drug submission and eCRT package preparation, including define.xml, eCRF, reviewer guide, ARM, BIMO and other related documents or procedure.

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, building successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.

Advanced knowledge of at least one data management system (Medidata Rave experience is a plus)

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.

Company info

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