Celgene Principal Programmer, Clinical 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:

Clinical trial databases:

  • Review synopsis and/or protocol and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting

  • Review protocols for proper data capture including case report form design

  • Assist Data Manager on development of eCRF specifications and review according to the protocol

  • Maintain in-house trials which could include (develop programming, testing and maintaining clinical trial databases) in accordance with Celgene standards

  • Review computer validation/edit checks if applicable

  • Developing, programming, and testing data review listings in SAS and/or reporting tool for data review purposes if applicable

  • Develop, programming, testing and maintaining computer validation/edit checks in RAVE, Oracle Clinical and/or Inform (Central Designer) if applicable

  • Act as liaison with vendors to establish transfer specifications and Celgene standards

  • Back-up peer programmer per assignment

  • Project manage multiple complex studies form startup through database lock

  • Participate in and lead team meetings when appropriate

  • Routinely interface with cross-functional team members

  • 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

  • Mentor junior programmers in more advanced programming skills

  • Participate in process improvement initiatives

Outside CROs:

  • Oversee CRO in the design and development of databases that are compatible with company needs

  • Oversee the CRO which involves the design and development of databases, review of appropriate documents e.g. DMP, Edit checks and monitor progress of clinical programming activities

  • Validation of output of CRO to ensure meets specification requirements

  • Liaise with CRO providers, when necessary, to ensure that Celgene standards are implemented in all studies

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Qualifications

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 systems is a must. Ability to take full advantage of all of applicable procedures and processes available in RAVE, Oracle Clinical and/or Inform (Central Designer).

  • 1 year of experience in RAVE is preferred

  • Participation in at least one NDA is preferred

  • Good communication skills; ability to work in a team environment with 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 programming

  • Computer skills: detailed knowledge of Oracle Clinical and/or Inform (Central Designer), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite

  • Experience managing clinical programmers a plus

  • 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.

Principal Programmer, Clinical

Location: Berkeley Heights, NJ, US

Job ID: 17001241