Job Details

Senior Manager, Open-Source Capabilities Lead

Clinical Development

Posted 17 days ago Full_time R1583290

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.

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. Read more: careers.bms.com/working-with-us.

The Opensource Lead position is responsible for overseeing the setup, configuration, and maintenance of opensource environments like R and Python, ensuring their seamless integration with existing technology. This role involves developing and enforcing SOPs and WIs to facilitate the compliant use of these technologies within the regulatory domain. Key responsibilities include managing workflows, ensuring security and compliance, providing training and support, and fostering collaboration and innovation. The Opensource Lead will stay up to date with emerging technology trends, evaluating and recommending new tools to enhance capabilities. They will work closely with IT to ensure smooth integration, address compatibility issues, and drive strategic planning efforts. Additionally, the role involves developing and executing a strategic roadmap to foster innovation, continuously improving processes to optimize the use of opensource tools and support organizational success.

Key Responsibilities:

  • Coordinate with stakeholders to understand requirements and deliver solutions that meet business needs.
  • Design and develop SOPs and Wis that support the adoption and integration of opensource technologies in the regulatory workflows.
  • Develop and execute a strategic roadmap for the adoption and integration of opensource technologies.
  • Identify emerging trends and technologies that can benefit the organization and drive innovation.
  • Conduct workshops and create documentation to promote the adoption of opensource technologies within the organization.
  • Stay up to date with the latest developments in R, Python and other relevant opensource technologies within the Clinical domain.
  • Work closely with IT and other departments to ensure seamless integration of opensource tools with existing technology infrastructure.
  • Assist in developing and socializing best practices for coding, testing, and deploying within R and Python environments.
  • Ensure
  • Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
  • Support the efforts of electronic submission process, preparation, and review on a global level.
  • Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
  • Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
  • Independently leads and / or performs programming assignments with minimal supervision

Minimum Requirements:

  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science, data science or life sciences required or equivalent.
  • At least 3 years programming experience in industry recommended.
  • For US positions: US military experience will be considered towards industry experience.
  • Demonstrated proficiency in using, R, python or other opensource programming languages to produce derived analysis datasets and TFLs.
  • Understanding of clinical data structure (e.g. CDISC standards) and relational database.
  • Demonstrated skills in using software tools and applications, e.g., MS office, XML.
  • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
  • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
  • Have good understanding of regulatory, industry, and technology standards and requirements.
  • Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirements:

  • Minimum of 3-5 years clinical / statistical programming experience within pharmaceutical clinical development
  • Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
  • Experience in other software packages (e.g. R)
  • Experience with the Linux operating system

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.