Principal Statistical Programmer bei SpringWorks Therapeutics
SpringWorks Therapeutics · Durham, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Durham
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.
Serves 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:
- Understanding of regulatory requirements for drug approval such as FDA, European Medicines Agency (EMA), Prescription Drug Marketing Act (PDMA);
- 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;
- SAS language for conducting clinical trials, including Base SAS, macro, SAS/STAT, SAS/GRAPH, SAS/Macro, and SQL;
- Creating define.xml, Pinnacle 21, ADRG, SDRG for clinical studies submissions to FDA, EMA, and Japan;
- Leading programming activities and timelines using tools such as Windows and Linux Operating Systems; and
- Cross functional collaboration with Clinical Operations, Project Management, Data Management, Statistician, and Pharmacovigilance using project management tools such as Microsoft Project or SmartSheet.
Salary: 40 hours/week; $160,000 - $260,000/yr.
Contact: Reference Job ID: 7722130 & 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).
