Senior Manager, Statistical Programming, SDTM Implementation

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. 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 .

Duties/Responsibilities

• Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, , SDRG, Annotated CRF) for BMS studies
• Serve as Study SDTM Programming lead for all regulatory submissions.
• Expertise in BMS SDTM automation tools, macros and using them for SDTM programming. Identify any inefficiencies and work with experts in up-versioning/enhancing existing tools and macros.
• Thorough knowledge of CDISC standards including CDASH/SDTM/ADaM and keep abreast of latest updates in the industry.
• Design/implement the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements. Work with standards team to design mapping algorithms for new items.
• Provide input to the design of the clinical trial database from an SDTM perspective.
• Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets.
• Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools to ensure regulatory compliance.
• Provide common language for repeated unresolvable validation issues across projects within a compound for inclusion in SDRG.
• Collaborate with stakeholders and Study team members to manage study timelines and resolve issues.
• Represent SDTM Programming function in Study team meetings as well as cross-functional working groups.
• Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies.
• Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables.

Participate in study/project team meetings as a core member and provide technical expertise/support.

Qualifications

• BA/BS in a relevant scientific discipline with more than 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM.
• Significant knowledge of SAS software and general computing as relates to clinical drug development.
• Knowledge of the drug development process, clinical trial methodology, CDISC Standards and familiarity with global regulatory requirements
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Ability to organize multiple work assignments and establish priorities

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 a supportive culture, promoting global participation 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 an 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 . Visit 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.

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