Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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 SDTM automation tools, macros and using them for SDTM programming
* Strong understanding of Rave EDC, SDTM metadata and metadata driven solutions
* Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model
* Design the SDTM specification as per the CDISC SDTM IG and BMS standards and ensure they meet downstream ADaM and Reporting requirements
* 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 other Quality tools
* 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 and process improvement activities
* Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains
* Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies
* Remain abreast with latest industry trends in standards implementation, review published papers and participate in industry conferences
* Direct responsibility preparing and presenting SDTM information cross functionally
* Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time
* Represent as internal team leader who decides best course of action
* Negotiate, assess, and monitor project priorities/timelines for SDTM components
* Review synopsis and/or protocol and provide comments for the Review Committee
* Provide programming input to CRF and External Data from an SDTM perspective
* Oversee development of SAS programs to generate SDTM datasets
* Validation of SDTM datasets to ensure meets regulatory compliance
* Provide input to the design of the clinical trial database from an SDTM perspective
* Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros
* Partner with CROs and act as a primary point of contact for SDTM programming activities
* Provide SDTM programming input into the SOW activities and review associated budget
* Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables
* Receive, process and review datasets, as well as data review reports from CROs
* Ensure that programming best practices are adhered to by both CRO and BMS programmers

Other Activities

* Build networks to achieve influence with other functions and represent as SDTM Programming technical expert.
* Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
* Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents
* Ensure consistency and adherence to standards and governance within their therapeutic area and the department
* Routinely interface with cross-functional team members during the study startup and execution.
* Lead/Participate in programming team meetings when appropriate
* Represent programming during internal audits as well as Health Authority audits
* Align with the department and company strategy and model

GBDS

GBDSProgramming

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.