Senior Principal Programmer

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

• 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.
• Ensure consistency and adherence to standards within their therapeutic area.
• 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 converting TFLs to the required format for eSubmission.
• Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
• Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
• Serve as the lead programmer in support of NDAs, sNDAs.
• Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
• Provide training on departmental SOPs/WPs and standard programs.
• Contribute to the creation of naming conventions and standards for the programming environment.
• Routinely interface with cross-functional team members.
• Influences other functions and represents as DOP technical expertise.
• Represent as internal team leader who decides best course of action.
• Coach and advise junior programmers to identify problems and solutions.
• Oversee the services provided by CROs.

• Bachelor’s degree with 9 plus years Pharmaceutical/CRO experience as a SAS Programm supporting clinical trials for regulatory submissions; or 8 plus years experience with a MS/MA degree.

Skills/Knowledge Required:

• Bachelor’s degree in life science, statistics, mathematics, computer science, or related field is required; Master’s
• degree is preferred.
• 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory
• submissions with a Bachelor’s degree; or 8 plus years experience with a MS/MA degree.
• 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 skills in using additional software tools and applications (e.g. MS office, XML).
• 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.
• In-depth understanding of regulatory, industry, and technology standards and requirements.
• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.
• Excellent planning and project management skills.
• Good interpersonal, communication, writing and organizational skills.
• Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM,
• ADaM, eDC.