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 will include, but are not limited to:

Programming Leadership:

* Responsible for supervising Programmers by planning/assigning their workload
* Act as a coach and mentor to Programmers
* Provide training and continued feedback to new programmers to ensure they understand Celgene standards and processes
* Participate in the development and execution of group strategy
* Resolve problems as they arise within defined procedures
* Begin building networks to achieve influence with others
* Influence other functions and represent as CDOSS technical expert
* Represent as internal team leader who decides best course of action
* Responsible for performance evaluations and development of direct reports

Programming Support:

* 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
* Provide programming support for the preparation of integrated reports, submissions and post-submission activities
* Serve as the lead programmer in support of NDAs, sNDAs

CRO and consultant Oversight:

* Coach Programmers on CRO database process
* Monitor progress of database activities in CROs working on Celgene-sponsored studies
* Participate in Study Team meetings as needed, especially in a supportive capacity

4. Other Key Activities

* Author, review, approve and train on CDOSS SOPs and Working Practices for the department
* Contribute to the creation, maintenance and validation of standards for programming tools, outputs and macros; and offering training on the same
* Ensure consistency and adherence to standards within their therapeutic area.
* Contribute to the creation of naming conventions and standards for the programming environment.
* Build interfaces between departments and troubleshoot issues as needed
* Assist in developing job descriptions for department including roles utilizing new technologies such as EDC
* Direct report responsibility for higher level Clinical Programmers
* Monitor projects to ensure that SOPs are properly followed and documentation is available
* Conduct special projects as assigned
* Sharing of best practices
* Participate in industry wide technical discussions

Skills/Knowledge Required:

* BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 8-10 years experience as a Clinical Programmer and SAS Programmer
* Supervisory experience a plus
* Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers
* In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices
* Medical or mathematics/computer science background a plus
* Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation
* Computer skills: detailed knowledge of at least one data management systems, basic familiarity with SAS datasets and conversion procedures
* Experience managing programmers, preferred
* Knowledge of clinical study design, Proficient in programming languages / software
* Advanced knowledge of reporting tools.
* Advanced knowledge of database design and programming practices
* Good understanding of clinical data and pharmaceutical development
* Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs
* Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
* Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
* Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
* Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs

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.