Senior Statistical Programmer

Job Title:

Senior Statistical Programmer

Company:
Spring Works Therapeutics (a healthcare company of Merck KGaA, Darmstadt, Germany)

Location:

100 Washington Blvd, Stamford, CT 06902;
Telecommuting permissible from any US location.

Salary: $114,330 - $165,000 per year.

Provide technical planning and oversee the setup of key macros and SAS programs. Act as a Lead Programmer for projects and consult with Clinical Data Management, Project Management, and Medical Writing. 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; develop technical solutions to abstract problems requiring 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 standards, including SDTM and ADaM for regulatory submission. Review draft and final production runs for projects to ensure quality and consistency. Contribute 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%.

• Provide technical planning and oversee macro and SAS program development.
• Lead programming projects and consult across departments.
• Define and enforce statistical programming standards.
• Develop and maintain data set specifications.
• Prioritize workloads and work with minimal supervision.
• Analyze complex problems involving quality of life, efficacy, and safety.
• Develop, validate, and maintain SAS/R programs for clinical trial reporting.
• Perform data quality checks and ensure data integrity.
• Program datasets per CDISC SDTM and ADaM standards.
• Review production runs for quality and consistency.
• Contribute to SOP development and implementation.
• Provide training and mentoring in statistical programming.
• Travel domestically up to 10%.

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

• 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.
• Knowledge of clinical trials including relevant regulations like ICH GCP guidelines (E6, E3, E8, E9), FDA requirements, EMA, and PMDA guidelines.
• 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.
• Creating CRTs (Case Report Tabulations) and listing reports using Study Data Tabulation Model (SDTM). Generate ADAM specifications and datasets.
• Cross functional collaboration experience working with Data Management, Statistician, PV and Clinical teams in Clinical development programs.
• 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.

Reference Job  & email resume to Kri

We offer best-in-class benefits for our team of Spring Workers who work with urgency on behalf of patients suffering from devastating diseases. Review additional information here Benefits.

Spring Works Therapeutics maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental…