Summary of Position:
Provides timely support to clinical study teams on all programming matters related to processing data from clinical studies. Creates, documents, and validates SAS programs, datasets, and outputs needed for the analysis, interpretation, and monitoring of MacroGenics clinical trials. Collaborates with the Data Manager, the Biostatistician, and the Database Designer to ensure that the clinical database and the data it contains are conducive to efficient and error-free SAS programming. Responds to both planned and ad-hoc data requests from Data Management, Clinical Operations, Product Safety, Medical Research, and Biostatistics. Uses and enforces CDISC STDM and ADaM standards.
* Creates/retrieves/uploads clinical data and metadata to/from/between Clinical Data Management Systems (CDMS) and other systems (IWRs, Labs, etc.).
* Programs, documents, and validates:
- Edit checks as specified in the Data Validation Plan for a given protocol,
- Tables/Listings /Graphs specified in the Statistical Analysis Plan,
- Tables and Listings needed for IBs and DSURs,
CDSIC SDTM and ADaM datasets,
- Data outputs requested by Medical Monitors to evaluate the conduct of their studies,
- Other deliverables requested by MacroGenics staff.
* Represents Clinical Programming at project team meetings and in interactions with IT and technology vendors for SAS related matters.
* Follows MacroGenics’ programming standards and provides guidance to SAS Programmers regarding standards Ensures standard processes are followed and quality assurance is maintained.
* Interfaces with CROs, vendors, and consultants involved in MacroGenics studies when SAS * Programming is outsourced. Raises issues and concerns in a timely manner.
* Works closely with the Data Manager, the Database Designer, and the Biostatistician to ensure that MacroGenics database are conducive to error free and efficient SAS Programming
* Perform review and quality check for statistical outputs and study reports and brings any errors or concerns to the attention of the appropriate parties.
* Provides documentation and consistent maintenance of code, logs, and output in a regulated environment
Bachelor’s degree in Mathematics, Computer Science, Statistics or related field of study. (Preferred – Master’s Degree in related area of study)
A minimum of eight years of SAS programming experience
Over five years of experience programming data from clinical trials
Experience with SAS Base, SAS Macro Language, SAS STATS, SAS/GRAPH, and SAS ODS a must.
Some experience working with Electronic Data Capture systems
Experience in different aspects of programming support in the clinical trials including study set-up, ad-hoc analyses, clinical study reports and evaluation of new technical solutions
Knowledge, Skills and Abilities
Knowledge of Oncology clinical trials and CDISC data models strongly preferred.
Versed in Good Clinical Practices
Familiarity with CDISC standards including the development of SDTM and ADaM preferred
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
Strong understanding of relational database structure.
Understanding of reporting systems utilizing multiple data delivery applications.
Experience with implementing standardization methodology.
Demonstrated ability to provide quality deliverables in a timely manner.
Demonstrated ability to work in a team environment
Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions.
Some experience in project management with supervision. Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.
Ability to support multiple assignments with challenging timelines.