Bristol Myers Squibb

Associate Director, Statistical Programming

3+ months agoSeattle, WA

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Associate Director Statistical Programming provide functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.

Associate Director Statistical Programming independently leads improvement initiatives under sponsoring of Therapeutic Area Head or Statistical Programming leadership team. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Managers also lead the change management process (e.g. communication, training, stakeholder engagement).

This position includes functional management responsibilities. In this role, Associate Director Statistical Programming is responsible for managing employees: set objectives, manage performance, and provide meaningful coaching and feedback. They also support the evaluation and recruitment of potential employees.

Key Responsibilities:

  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
  • Drives the development and implementation of innovative strategies and technologies for clinical trial programming
  • Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
  • Leads the electronic submission preparation and review
  • Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
  • Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities

Improvement Responsibilities:
  • Drives, Identifies, leads, and supports opportunities to enhance processes and technology
  • Communicates proactively and effectively around issues and risks and contributes to its remediation

Managerial Responsibilities:
  • Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains 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 manager
  • 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 manager 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
  • Act as extended member of Statistical Programming Leadership Team in sharing and building up the line function vision

Minimum Requirements:
  • Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
  • At least 10 years programming experience in industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment
  • For US positions: US military experience will be considered towards industry experience
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
  • Broad expertise in statistical programming and in developing computing strategies
  • In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
  • Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
  • Demonstrated ability to work in a team environment with clinical team members

Preferred Requirements:
  • Member of industry organizations or presented at Congresses/Conferences

#GBDS

#GBDSProgramming

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.