Senior Principal Programmer

Celgene

(Berkeley Heights, New Jersey)
Full Time
Job Posting Details
About Celgene
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.
Responsibilities
- 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.
Ideal Candidate
* 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.

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