Principal Statistical Programmer

Serve as a subject matter expert who develops all files using features in SAS and other programming languages, including Standard and Analysis datasets, tables, listings, and figures in word and pdf form, documents, and analyses (e.g., safety and efficacy) necessary to support an electronic submission in eCTD format. Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency and ensure compliance with SOPS and global regulations (e.g., ICH, FDA, EMA, PMP). Independently and collaboratively solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and promptly.  Works cross-functionally within Biometrics, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities and teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies. Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDLSC data submission. Creates and maintains project timelines, delegating programming assignments to internal and external programming resources. Trains and onboards new staff, both internal and external and serves as a mentor to other statistical programmers at lower levels. Must be available to work in office two days a week.  Work from home is acceptable three days a week.  

REQUIREMENTS: Master’s degree or foreign degree equivalent in Mathematics, Statistics, Biostatistics, Computer Science, Data Science, or related field and five (5) years of experience in Statistical Programming/ SAS Programming-related role or in the job offered.

Skills: Experience and/or education must include:

1. Understanding of regulatory requirements for drug approval such as FDA, European Medicines Agency (EMA), Prescription Drug Marketing Act (PDMA);

2. Knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards for conducting clinical trials such having experience developing, validating, and translating specifications mapping EDC data to SDTM, SDTM to ADaM, and ADaM to TLFs;

3. SAS language for conducting clinical trials, including Base SAS, macro, SAS/STAT, SAS/GRAPH, SAS/Macro, and SQL; 

4. Creating define.xml, Pinnacle 21, ADRG, SDRG for clinical studies submissions to FDA, EMA, and Japan;

5. Leading programming activities and timelines using tools such as Windows and Linux Operating Systems; and

6. Cross functional collaboration with Clinical Operations, Project Management, Data Management, Statistician, and Pharmacovigilance using project management tools such as Microsoft Project or SmartSheet.

Job Site: 9 Laboratory Drive, Suite 200, Durham, NC 27709; Must appear in office 2 days per week; WFH permissible 3 days per week.

Salary: 40 hours/week; $160,000 - $260,000/yr

Contact: Reference Job ID: 7722130 & email resume to Kristen.Turner@SpringWorkstx.com