Senior Statistical Programmer

Provide technical planning to include overseeing the set-up of key macros and SAS programs. Act as a Lead Programmer for projects. Act as a Statistical Programming consultant to other departments e.g. Clinical Data Management, Project Management and Medical Writing. Ensure quality of personal work and the work of the team when acting as a Lead Programmer. Define and enforce statistical programming standards and best practices to promote consistency and maintainability. Develop and maintain clear data set specifications to ensure data integrity and facilitate analysis. Prioritize personal workload and that of teammates; perform work with minimal supervision. Work on complex problems where analysis of situations or data requires an evaluation of intangible variables such as quality of life, treatment efficacy, and safety; development of technical solutions to abstract problems which require the use of ingenuity and creativity. Develop, validate, and maintain SAS, R, or other statistical programs to support data analysis and reporting for clinical trials, including the creation of tables, listings, and figures (TLFs) as per protocol specifications. Perform data quality checks and ensure data integrity by conducting routine data cleaning and validation tasks, identifying and resolving discrepancies, and working closely with data management teams. Program datasets in accordance with CDISC (Clinical Data Interchange Standards Consortium) standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) for regulatory submission. Review draft and final production runs for project to ensure quality and consistency. Contributing to the development and implementation of SOPs. Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development. Perform other duties and responsibilities as assigned. Domestic travel required, 10%. Telecommuting permissible from any location within US.

REQUIREMENTS: Bachelor’s degree or foreign degree equivalent in a Computer Science, Life Science, Statistics, or related field and seven (7) years of progressive, post-baccalaureate experience in the Statistical Programming or related role or job offered.

Skills: Experience and/or education must include:

1. Developing programs for extensive statistical analysis of data using Base SAS, SAS/STAT, SAS Graph, SAS Macro Language and SAS procedures for core functionality of data manipulation, data management, and basic statistical analysis including PROC MEANS, PROC ANOVA, PROC TABULATE, ODS Output;

2. Knowledge of clinical trials including relevant regulations like ICH GCP guidelines (ICH E6, ICH E3, ICH E8, ICH E9), FDA requirements, EMA, and PMDA guidelines;

3. Creating, implementing and maintaining SAS macro library for production of statistical tables/figures/listings, developing data editing checks in SAS, and developing and extensively use existing SAS macros for Validation, Analysis and Report generation;

4. Creating CRT's (Case Report Tabulations) and listing reports using Study Data Tabulation Model (SDTM) Model. Generate ADAM specifications and datasets;

5. Cross functional collaboration experience working with Data Management, Statistician, PV and Clinical teams in Clinical development programs; and

6. Create safety and efficacy TLF-derived analysis reports by using SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/MACRO to create reusable code snippets, automating tasks and making analysis more efficient.

Contact: Reference Job ID: 9296733 & email resume to Kristen.Turner@SpringWorkstx.com