Principal Database Developer (India)

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development., Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

Ihre Aufgaben

The Database Developer performs clinical EDC programming activities and various programming deliverables (e.g SAS listings) within the data management group for assigned projects.,

• Provide technical support for clinical data management projects across multiple therapeutic areas.

• Coordinate the design, develop, and improve the clinical database.

• Program data edit checks.

• Work closely with data management to ensure data quality.

• Contribute to EDC programming and reporting activities.

• Work as part of a data management team developing SAS templates and utilities for data cleaning and reporting.

• Communicate with all levels of internal team members and sponsors.

• Perform quality control measures on deliverables.

• Understand and support clinical data management needs.

• Develop screens, validation checks, back-end programming, and listings during database development and coordinate the testing of the database prior to release into production as well as the subsequent release into production once approved.

• Act as a liaison with the clinical data management team on system change requests to current study database in order to understand potential issues and technical impacts.

• Coach and mentor other Database Developers in all areas of database developments

• Facilitate process improvements for EDC and paper-based systems.

Ihr Profil

Education: Bachelor degree in Life Sciences, Computer Science or related discipline.

Experience: A minimum of 5 years of progressive hands-on experience in Clinical Data Management or Clinical Research,

• Expert in SAS programming

• Proficient in at least one of the prevalent EDC tools (Medidata Rave, IBM Clinical Development, Medrio, VieDoc, Oracle, InForm)

• Good Knowledge of data, databases and data procedures.

• Strong CDASH and SDTM knowledge (SDTM Annotation, Data mapping and SDTM Controlled Terminology)

• Medidata builder and/or IBM Clinical Development designer

• Strong Knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents (SOPs/Guidelines/Work Instructions)

• Flexible and proactive with an ability to work independently and in a team environment

• Detail-oriented with analytical mind-set.

• Good problem-solving skills.

• Project management and negotiation skills

• Proficient with Microsoft office suite (Excel, Word, PowerPoint)