About SpringWorks Therapeutics:

SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.

We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN).

At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for.

Job Description: 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:

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 (ICH E6, ICH E3, ICH E8, ICH 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 CRT's (Case Report Tabulations) and listing reports using Study Data Tabulation Model (SDTM) Model. Generate ADAM specifications and datasets;
Cross functional collaboration experience working with Data Management, Statistician, PV and Clinical teams in Clinical development programs; and
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 [email protected]

We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

EEO Statement:
SpringWorks 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 disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks’ Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

Privacy:
Upon submission of this form I understand that SpringWorks Therapeutics is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S.. Information about SpringWorks Therapeutics’ privacy practices can be found at Privacy Policy - Springworks (springworkstx.com).

Senior Statistical Programmer

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