Senior Clinical Programmer (SDTM) - homebased, Bloemfontein

Senior Clinical Programmer (SDTM) - homebased Bloemfontein, South Africa | Full time | Home-based | R1530371

Review and provide input into all trial set-up documentation

Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.

Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards

Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review

QC of all clinical programming deliverables

Perform unblinding, data-cut activities for planned reporting milestones and database locks

Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.

Support the development of standards and drive implementation within the organization

Experience

Minimum 4+ years of relevant experience in

SDT

M Clinical Programming

Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL,

Python, R , etc.)

Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.

Advanced knowledge of

SDTM including Define.xml, CDASH, and metadata

as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus

Demonstrated understanding of current industry standards for submission of clinical trial data.

Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.

Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.

#J-18808-Ljbffr