Senior Specialist, Statistical Programmer

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 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 Data Definition Tables (DDT) 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. • 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. • Activities are not limited to for Celgene KK, for other countries if necessary. 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 understanding 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, Data Definition Table, electric data submission. • 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). 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.