Celgene Principal Programmer, Statistical in Berkeley Heights, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

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.

  • Perform programming validation to ensure the quality of analysis datasets and programming outputs.

  • Ensure consistency and adherence to standards within the project.

  • 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.

  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.

  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.

  • Serve as the lead programmer in support of NDAs, sNDAs.

  • Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.

  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.

  • Contribute to the creation, maintenance, and validation of standards for outputs and macros.

  • Provide training on SOPs, WPs and standard programs.

  • Contribute to the creation of naming conventions and development of the programming environment.

  • Oversee the services provided by CROs.

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Qualifications

Skills/Knowledge Required:

  • Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred.

  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.

  • Demonstrated proficiency in using SAS to produce derived analysis datasets and 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.

  • Good planning and project management skills.

  • Good interpersonal, communication, writing and organizational skills.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Principal Programmer, Statistical

Location: Berkeley Heights, NJ, US

Job ID: 17001752