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Celgene Corporation

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide.At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission 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.There are more than 300 clinical trials at major medical c... Read More

Address      86 Morris Avenue Summit, NJ 07901
Website      www.celgene.com
Holding      No Holding Details

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Principal Clinical Programmer Job

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.


BA/BS in a relevant scientific discipline; minimum five years programming experience in a pharmaceutical/CRO setting.

Responsibilities will include, but are not limited to:

1. Clinical trial databases:

- Review synopsis and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting
- Review protocols for proper data capture including case report form design
- Review eCRF specification according to the protocol
- Assist Data Manager in eCRF development
- Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical or Central Designer in accordance with Celgene standards
- Review computer validation/edit checks for in-house and outsourced studies
- Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS
- Develop, program, test and maintain data review listings in Oracle Clinical, Inform, Jreview and/or SAS for data review purposes
- Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Celgene standards
- Validate peer programming
- Participate in and lead team meetings when appropriate
- Act as primary CRO contact, when necessary, to ensure that Celgene standards are implemented in all studies
- Provide technical expertise and support to Data Management team
- Control access to database and perform snapshots, database lock and freeze activities
- Make data, including interim data, available to company personnel and regulatory agencies when required
- Perform post processing of data extracts in accordance with Celgene standards to be delivered to Biostatistics
- Routinely interface with cross-functional team members
- Influences other functions and represents as DBO technical expertise
- Internal team leader who decides best course of action
- Coach and advise junior programmers to identify problems and solutions

2. Manage outside CROs and consultants:

- Review clinical programming activities and costs in contracts
- Assess CRO data management systems for regulatory compliance
- Interact with CROs in the design and development of databases that are compatible with company needs
- Monitor progress of clinical programming activities in CROs
- Participate in regular team meetings and provide input when appropriate

3. Other Activities

- Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock.
- Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities
- Direct responsibility for supervising and training junior clinical programmers in the performance of their duties
- Managing project priorities and timelines

Skills/Knowledge Required:

- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience
- Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems).
- Experience managing clinical programmers
- Participation in at least one NDA is preferred
- Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
- Medical or mathematics/computer science background a plus
- Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
- Knowledge of SQL and SAS programming
- Computer skills: detailed knowledge of clinical database design (Oracle Clinical or Inform), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
- Knowledge of clinical trial design and basic statistics (a plus)

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.

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Full Time

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