The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. And the problem is only getting worse.
TrialSpark finds new medicines and develops them cheaper and faster, using our proprietary trial engine.
As a Clinical Programmer/Analyst, you will play a key role in the execution of TrialSpark’s full study offering. We are looking for an experienced programmer who can execute our Unified Data Layer strategy and deliver fast, high quality data to support our studies. As part of your role, you’ll partner closely with other leaders across the company, contributing to TrialSpark’s broader Clinical Trial Engine strategy and build out.Duties and Responsibilities
Duties include but are not limited to:
Key responsibilities will include:
- Using industry knowledge, experience, and first-principles thinking to refine our strategy for delivering key study services, with a primary focus on Project Management.
- Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.
- Develop, program and test reports using SAS and/or R to identify anomalies and support data review efforts and maintain already developed reports using SAS.
- Perform pre-processing and loading of non-CRF data file formats including but not limited to csv, txt, sas7bdat, XPT, JSON.
- Develop solutions for ingesting data from several data formats, mapping to standard structure and develop dashboards and analytics on a chosen endpoint solution.
- Program reports for clinical trial management and operational oversight. Work with 3rd party vendors and external data acquisition lead for data loading, integration, and reconciliation at study level.
- Conduct peer review and technical review of clinical programming deliverables in close collaboration with Product & Engineering teams.
- Participate and contribute towards internal user group meetings to share knowledge and provide latest updates/features. Participates in Clinical Data Management department initiatives.
- Contribute to the development and maintenance of processes, tools, best practices, and metrics relating to tracking and analyzing clinical trial programming quality
Skills, abilities, and knowledge
- Critical thinker with the ability to step back and rethink legacy assumptions in the clinical research space; should be able to point to what’s wrong, and how you would do it differently if starting from scratch.
- Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives and meet timelines.
- Superior written and oral communication skills; can synthesize complex concepts and deliver messages clearly.
- Demonstrated proficiency in SAS data step programming, macros, and SQL.
- Knowledge of R for data visualization development as well as Business Intelligence tools such as Mode, Looker, or Tableau preferred, but not required.
- Working knowledge of SAS/R to extract, transform, and load data from AWS S3 and/or Redshift a plus.
- Knowledge of CDISC/SDTM and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submissions.
- Ability to ensure clinical database programming and report development work is completed in a consistent manner and validated according to department practices.
- Knowledge of GCP and other regulations.
Education and Experience
- 4-5+ years clinical research industry experience
- 3+ years of clinical programming experience at a biopharma company or CRO
- SAS Certified Advanced Programmer certification preferred, Data Management and/or Administration certifications a plus (Those without certification will be considered after technical assessment)
- BS required, preferably in life sciences or a related field; advanced degree preferred
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.