Associate Director Statistical Programming - Standards & Analytics

Posted 24 days ago
Main Location
New York City, NY, United States
Open jobs
  • 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 GBDS
    • 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 with a minimum of 10 years clinical trial related experience or Bachelor’s degree with at least 15 years’ experience
    • Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing techniques
    • Experience leading a large cross-functional initiative, or (at minimum) a work stream within a capital project
    • Thorough knowledge of CDISC® standards (both SDTM & ADaM) and hands on experiences of leading all types of SDTM/ADaM domains design, development and validation
    • Knowledge of and hands-on experience with metadata driven approaches
    • 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
    • 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

    Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    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 with the resources to pursue their goals, both at work and in their personal lives.

    Mission
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    Associate Director Statistical Programming - Standards & Analytics
    Bristol Myers Squibb