Sr. Manager, SDTM Implementation, Statistical Programming

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.

Position Summary

This position provides expertise to drive excellence and consistency in statistical programming SDTM implementation team.  Primarily, this position is responsible for providing strategic oversight to project deliverables and related technologies that support analysis and reporting activities.  This person will provide technical expertise, as required, to development teams and serve as a point of escalation for issues unable to be resolved at the team level. 

Position Responsibilities

• Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, 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

Key Competency Requirements

• BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 7 plus years of experience supporting clinical trials for regulatory submissions
• Experience as a Lead Programmer overseeing SDTM activities of support programmers as well as CRO/external vendors
• Train junior programmers on company standards and processes. Serve as a point of escalation for issues that cannot be resolved by support Programmers.
• Expert experience with CDSIC standards including CDASH or SDTM/ADaM.
• Thorough understanding of MDR concepts and ability to interact with Standards Governance bodies to impart compound specific knowledge for change requests.
• Hands on experience using SDTM validator tools such as  Pinnacle21. Identify common issues, diagnose the root cause and provide standard language for submissions package.
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
• Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, EDC, SDTM.
• Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission.
• Proficient in programming languages and demonstrated proficiency in using SAS to produce SDTM datasets.
• In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices.
• Demonstrate ability to work in a team environment with clinical team members
• Excellent communication skills, excellent written, verbal, interpersonal and organizational skills
• Excellent planning and project management skills as well as vendor management.

Degree Requirements

BA/BS

Experience Requirements

• Minimum of 7 years clinical/statistical programming experience within pharmaceutical clinical development

Travel Required (nature and frequency). Enter “N/A” if not applicable.

N/A

Describe exposure to any hazards/disagreeable conditions in the work environment. Enter “N/A” if not applicable.

N/A

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 [email protected]. 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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