Senior Principal Programmer, Statistics

Job Title:
Job ID: 14130
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Programming - 3623

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

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:

1. Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
2. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
3. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
4. Ensure consistency and adherence to standards within their therapeutic area.
5. Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
6. Serve as the lead programmer in support of NDAs, sNDAs.
7. Oversee the services provided by CROs.
8. Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
9. Provide training on departmental SOPs/WPs and standard programs.
10. Contribute to the creation of naming conventions and standards for the programming environment.
11. Participate in industry wide technical discussions.

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 (eg MS office, XML).
- Demonstrated expertise in the handling and processing of upstream data, eg, multiple data forms, workflow, eDC, SDTM.
- Demonstrated expertise in providing outputs to meet downstream requirements, eg, 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, eg, CDISC, SDTM, ADaM, eDC.

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.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.