Associate Director, Statistical Programming San Francisco, CA/Hybrid

About QED Therapeutics & BridgeBio PharmaQED Therapeutics, an affiliate of BridgeBio Pharma , focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.Our business is inspired by our values : PUT PATIENTS FIRSTEVERY MINUTE COUNTSTHINK INDEPENDENTLYBE RADICALLY TRANSPARENTFGFR=fibroblast growth factor receptor.BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas.Associate Director of Statistical Programming will lead the statistical programming activities for multiple studies and programming submission-related activities. In addition to work as a hands-on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.Responsibilities This position will play a crucial role in a specific therapeutic area, offering programming support across various stages of clinical trials to ensure the timely delivery of high-quality outputs.Responsibility includes overseeing the quality and management of the CRO’s work, as well as collaborating regularly with Biostatisticians, Clinical Data Managers, Medical Writing, Clinical Operations, Drug Safety, Regulatory and other team members.Provide valuable input into key study documents such as Case Report Forms (CRFs), data management plans, database specifications, Statistical Analysis Plans (SAPs), and other clinical documents.Provide statistical programming expertise on the production and validation of tables, figures, and listings (TFLs).Write or review data specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).Oversee programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions.Collaborate with internal team members effectively to help develop / enhance / maintain global macros.In addition to hands-on programming, this position may require managing and providing oversight of one or more team members / contractors.Development of comprehensive project plans, including task breakdowns, timelines, and resource allocation.Anticipate potential challenges and devise contingency plans to address unforeseen difficulties.No matter your role at BridgeBio, successful team members are : Patient Champions, who put patients first and uphold strict ethical standards.Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset.Truth Seekers, who are detailed, rational, and humble problem solvers.Individuals Who Inspire Excellence in themselves and those around them.High-quality executors, who execute against goals and milestones with quality, precision, and speed.Education, Experience & Skills Requirements MS, BS / BA degree in Statistics, Mathematics, or Computer Science, or other suitable qualification with relevance to the field.At least 10 years of Statistical Programming experience in biotech, pharmaceutical industry, or CRO.Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM / ADaM standards.A comprehensive understanding of SAS / BASE, SAS / STAT / , SAS / GRAPH and SAS macro languages.A demonstrable record of strong leadership and teamwork.Proficient in managing multiple projects with a demonstrated ability to prioritize tasks.Demonstrate a strong sense of accountability and ownership for assigned projects.What We Offer Patient Days, where we hear directly from individuals living with the conditions we are seeking to impact.A culture inspired by our values.A de-centralized model that enables our program teams to focus on advancing science and helping patients.A place where you own the vision – both for your program and your own career path.A collaborative, fast-paced, data-driven environment.Access to learning and development resources.Robust and market-competitive compensation & benefits package.Flexible PTO.Rapid career advancement for strong performers.Commitment to Diversity, Equity & Inclusion.#J-18808-Ljbffr