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)
- 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

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

S k ills/ K n o wledge Required:
- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 8-10 years experience as a
- C linical 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
- Detailedknowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation
- Computer skills: detailedknowledge of at least one data management systems, basic familiarity with SAS
- d atasets 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 meetdownstream requirements, e.g., ADaM, Data
- Definition Table, e-submission
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs

Qualifications
- B A/ B S in a relevant scientific discipline; minimum 7-10 years experience as a clinical/ o r SAS programmer in a pharmaceutical/CRO setting.