Working with UsChallenging. 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.This position providesexpertiseto drive excellence and consistency in statistical programming SDTM implementation team.Primarily, this positionis responsible forprovidingstudy SDTMdeliverables that support analysis and reporting activities.Primarily responsible for quality andtimelydelivery of SDTM artifactsrequiredfor downstream activities and regulatory submissions.Review synopsis and/or protocol and provide comments for the Review CommitteeDesign SDTM specification as per Company CDISC standards and ensure they meet downstream ADaM and Reporting requirementsUnderstand different formats of data collection including CRF and non-CRF(external) data and the challenges involved in integration of the two sources into target SDTM model.Annotate CRFs and Review annotated CRFsin accordance withBMS guidelines andappropriate metadatato reflect tabulation datasetsOversee/ develop SAS programs to generate SDTM datasetsCreate and/or validateeCRTpackage for regulatory submission.Working knowledge of BMS SDTM automation tools,macrosand metadata.Intricate understanding of clinical developmentlife-cycle, stake-holder interactions and data interactions that aid in identification of issues root-cause.Maintain highquality ofdeliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools and ensure the quality meets regulatory submission standards.Collaborate with stakeholders and Study team members to manage studytimelines, andresolve issues and escalate if necessary.Ensure that all programming deliverables are compliant with CDISCPartner with CROs and act as a primary point of contact for SDTM programming activitiesProvide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality andtimelydeliverablesReceive, process and review datasets, as well as data review reports from CROsEnsure that programming best practices are adhered to by both CRO and BMS programmersParticipate in study/project team meetings as a core member and provide technicalexpertise/supportDegree RequirementsBA/BS in a relevant scientific discipline such as Life Sciences, Pharmaceutical sciences, Statistics, or Computer science.Experience RequirementsMinimum of 4 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM with an end to end understanding of clinical drug development lifecycle. Please see job description for detailed expected experience.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 CareersWith 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 ProtocolBMS 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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.
