Xilio Therapeutics

Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments.. Data standards development and adherence including guidance on data continuum; drives strategy to ensure compliance with CDISC standards for all development programs to ensure regulatory submission compliance. Ensures the clinical data/statistical programming vendor’s technology processes meet or exceed the regulatory requirements to support Xilio’s global development projects. Proficiency in R programming as well as SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS and SAS/SQL in a clinical data environment with excellent analytical skills. Excellent knowledge of CDISC standards (SDTM and ADaM)

sr director

Director/Sr. Director Clinical Data Sciences and Programming Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize their therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines and antibodies (including bispecifics) and immune cell engagers (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers). Learn more by visiting <a > </a> and follow us on LinkedIn (<a >Xilio Therapeutics, Inc </a>.) SUMMARY: The Senior Director/Director Clinical Data Sciences & Programming is responsible for driving data extraction, programming and reporting in alignment with the clinical protocol and industry standards.  Responsibilities include oversight of CRO-led implementation, execution, delivery/reporting, and submission of clinical data.  This position reports to the Vice President Clinical Operations. Responsibilities <ul><li>Lead, coordinate and oversee the development of integrated programing solutions serving the full spectrum of programming needs to support ongoing clinical studies and requests for clinical study reports, regulatory submissions and ad hoc/post hoc analysis </li><li>Work closely with internal partnering functions, collaborators and CROs to ensure all programming results are delivered in a timely manner with high quality </li><li>Perform, coordinate and implement the following: </li><ul><li>Programming, testing and documentation of statistical programs for use in creating statistical tables, figures and listings </li><li>Programming of analysis datasets (derived datasets) and transfer files for internal and external use </li><li>Programming quality control checks for the source data </li><li>Develop and maintain programming documentation and specifications following programming standards and processes </li> </ul><li>Interpret project level requirements and develop programming specifications for complex studies </li><li>Data standards development and adherence including guidance on data continuum; drives strategy to ensure compliance with CDISC standards for all development programs to ensure regulatory submission compliance </li><li>Provide insight on latest technologies and changes in regulatory environments, enabling proactive approach and planning to meet future requirements and efficient study and data management support of global development programs </li><li>Ensures the clinical data/statistical programming vendor’s technology processes meet or exceed the regulatory requirements to support Xilio’s global development projects </li><li>Support global regulatory authority submissions including preparing programming deliverables for submission and working closely with partnering functions to address health authority requests </li><li>Estimate programming scope of work, manage resource assignments and negotiate project timelines for deliverables </li><li>Planning and management of external budgets related to data technology licensing, hosting and deliverables </li> </ul>Required Qualifications <ul><li>A minimum of a bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline </li><li>12+ years of programming experience preferably in processing oncology clinical trial data in the biotechnology, pharmaceutical or health related industry including 3+ years leading technical teams </li><li>Proficiency in R programming as well as SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS and SAS/SQL in a clinical data environment with excellent analytical skills </li><li>Excellent knowledge of CDISC standards (SDTM and ADaM) </li><li>Previous experience completing multiple complex clinical studies in oncology.  Phase I-III experience preferred including IND, NDA, and BLA filings </li><li>Experience in effectively managing CROs and other technical partners </li><li>Strong verbal and written communication skills </li><li>Work well in a cross functional team environment, both independently as well as be willing to help others </li><li>Excellent working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines and other applicable regulatory regulations and guidelines </li><li>Strong attention to detail and creative problem-solving skills are essential </li><li>Goal oriented, organized, capable of working on multiple projects, and able to execute to timelines that meet company goals </li><li>Evidence of commitment to innovation and patient-centricity </li><li>Ability to work independently and in a highly collaborative team environment </li> </ul>Diversity, Equity and Inclusion At Xilio Therapeutics, we foster a culture of equity, diversity and inclusion.  We consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to #LI-NM1 #J-18808-Ljbffr

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