Job Description Req #: 1900290
Location: Berkeley Heights, New Jersey, United States
Job Category: Information Technology
Work Location: 300 Connell Dr 07922
Organization: Clinical Programming
Employee Status: Full-time
Job Type: Regular
Senior Principal Statistical Programmer
Bachelor's degree with 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions; or 8 plus years experience with a MS/MA degree.
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.
* 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 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.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is a biopharmaceutical company.