Clinical Data Programmer
Description

miRagen Therapeutics is currently seeking an entry- to mid-level clinical data programmer to become an integral member of the Clinical Development team.  The position requires experience writing programs and macros in SAS as well as clinical database design/programming in Medidata Rave.  The ideal candidate will also demonstrate a desire to help build the clinical programming infrastructure and be an important part of our direction and efficiency as we grow. Primary responsibilities include:


• Develop and validate SAS programs that are used to create datasets (SDTM, ADaM) and output (tables, listings, figures) for presentations (ASCO, ASH, etc.), regulatory authorities (CSR, IB, DSUR, etc.) as well as for internal decision making.

• Create and validate SAS macros to be used across studies and programs that streamline repetitive operations to increase programming efficiency.

• Design, develop and test clinical databases in Medidata Rave.  This includes form design, edit check configuration and eventually custom function programming in C#.

• Gather requirements for both form design as well as edit check specifications.

• Interact with both internal and vendor database development, data management, clinical operations, safety, biostats, etc... groups to insure all work is being done in the most efficient manner.


Requirements

• BS/BA in Statistics or Computer Science or related discipline and minimum 2 years’ experience (4+ for mid-level) programming in the pharmaceutical/biotech industry.

• SAS programming including base, macro and graph

• Knowledge of CDISC standards, in particularly SDTM, ADaM and define.xml

• Clinical database experience both designing forms as well as programming edit checks preferably in Medidata Rave

• Demonstrated creativity and independent judgment

• Willingness to be flexible and adaptable

• Ability to work collaboratively with industry and academic partners

• Exceptional interpersonal skills and the ability to work and communicate effectively within a multi-disciplinary team

• Strong initiative and ability to work effectively under general supervision



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