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

Responsibilities will include, but are not limited to, the following:

• Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
• Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
• Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
• Perform programming validation to ensure quality of analysis datasets and programming outputs.
• Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
• Create TFLs shell (Data Presentation Plan) and convert TFLs to the required format for electric data submission.
• Create SDTM/ADaM datasets (including legacy study) and relevant documents for electric data submission.
• Leads / Supports the electronic submission to PMDA.
• Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
• Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
• Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
• Contribute to the creation, maintenance, and validation of standards for outputs and macros.

Skills/Knowledge Required:

• Bachelor’s degree in life science, statistics, mathematics, computer science, or related field required; Master’s degree is preferred.
• 5 plus years Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions.
• Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
• Have in-depth understading of clinical data structure 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., CDISC, SDTM, ADaM, Have in-depth 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.
• Demonstrated ability to work with Global colleagues (TOEIC score: 700 is preferable). Activities as staff/manager:
• Propose improvement of issues in stat programming tasks to statistical group
• Participate in activities for improvement.
• Review the process of stat programming tasks with quality following regulation in Japan.
• Collaborate with global stat programming group for improvement if necessary.
• Participate in trainings, workshops, and conferences and feedback to statisticians, programmers and colleagues in other functions.
• Routine interface with cross-functional team members and CRO members.
• Lead stat programmers and manage resources, budget, and project priorities and timelines in collaboration with supervisor.

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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1598060 : Senior Specialist, Stat Programming