Associate Director, Statistical Programming

3 weeks ago

Berkeley Heights, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Associate Director, Statistical Programming, provide s 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 d rives the development and implementation of innovative strategies and technologies for clinical trial programming. A ssociate Director develop collaborative relationships and work effectively within Gl obal Biometrics & Data Sciences (GBDS), with external vendors and members of cro ss-functional development teams.

Associate Director, Statistical Programming, independently lead s 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: se t objectives, manage performance, and provide mea ningful coaching and feedback. They also support the evaluation and recruitment of potential employ ees.

**Project 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
- Lead s the electronic submission preparation and review
- Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
- R ev iews planning documents (e.g., statistical analysis plan, data presentation p lan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements ; A ssess es document robustness and impact on progr amming 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

**Skills, knowledge, and e **xperience**

**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,

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