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


    • 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

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    Associate Director Statistical Programming - Standards & Analytics
    Bristol Myers Squibb