21 director biostatistics jobs found

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Legend Biotech USA Legend Biotech is seeking Sr. Director Biostatistics and Data Analytics as part of the Clinical Development team based Remotely. Role Overview Legend Biotech is seeking a dynamic and strategic Senior Director of Biostatistics & Data Analytics to lead and build out the Data Analytics function across our BCMA and broader pipeline programs. This highly visible role will be responsible for overseeing all Biostatistics, Statistical Programming, and Data Management activities, ensuring the highest standards of scientific and operational excellence for our CAR-T cell therapy studies in for early and late-stage development. The ideal candidate brings deep biostatistics expertise, proven leadership, and hands-on experience in guiding clinical trial design and execution. Reporting directly to the Chief Medical Officer, this individual will play a key role in shaping Legend's data strategy, leading complex development programs, and driving...

Alkermes, Inc. Responsible for all aspects of project and trial strategic leadership, design, planning, communication. Supervises internal junior biostatistician, provides project team and functional support, and oversees CRO biometrics groups. Performs trial design, planning, interim and final statistical evaluations and reporting. Presents results and interpretation to internal and external audiences, including regulatory authorities. Supports due diligence and regulatory negotiation, as well as research collaboration projects. Responsibilities Position Summary: This unique position offers an ambitious candidate the opportunity to contribute and learn through direct exposure to a wide spectrum of biometrics activities in support of Clinical Development, Regulatory Agency submissions, and Medical Affairs, including a strong focus on Real World Evidence (RWE). The incumbent will be responsible for planning and executing a range of biostatistical activities to support...

Biogen The Associate Director of Biostatistics is responsible for leading complex projects in support of Medical Affairs priorities. The incumbent acts as sole point of contact from Biostatistics with multiple stakeholders across the business. He/she leads the planning of analyses and design of studies with appropriate analytical rigor to generate evidence which addresses questions of importance for patients, prescribers, and payers. Applying the best, current statistical and causal inference approaches, the AD ensures analysis results are sound and interpretable. The AD contributes as a coauthor on scientific publications and disclosures and HTA dossiers to disseminate analysis results and interpretations. The AD ensures timely delivery of analyses and other work products and maintains strong collaborative relationships with key stakeholders. He/she also contributes to the long-term strategy of the Biostatistics department and business partner departments by contributing to...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Responsible for the design and implementation of PMX strategy on the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Director, Clinical Development is responsible for the development, execution and management of several clinical programs worldwide across all phases of clinical research. The individual will oversee study teams and will be responsible for leading cross-functional teams in...

Biogen Develops, directs and oversees global activities in the areas of Biostatistics function, including the development and implementation of strategic organizational and staffing plans for the department in support of overall corporate goals Manages the performance and career development of subordinate staff, and provides consultation to department management team, as necessary, to develop and optimize the overall productivity and performance of Biostatistics staff and establishes and ensures the visions and goals of Biostatistics are in-line with the corporate goals; communicates the visions and goals to the Biostatisticians; provides guidance to the visions and goals of Biometrics Oversees, through subordinate management staff, the work of project data associates and programmer analysts to ensure the validity and accuracy of the summary tables, graphs and data listings for the integrated statistical/clinical report within one or multiple therapeutic area(s) Serves...

Legend Biotech USA Legend Biotech is seeking a Medical Director as part of the Clinical Development team based in Somerset, NJ. Role Overview The Clinical Research Physician (CRP) is a critical role in the company with significant impact on the development and life cycle of drug development projects. The Clinical Research Physician will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Medical Affairs, Translational Development, Market Access, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission and managing the Clinical Research Scientists, if applicable. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within...

GSK The Interventional Study Scientist Medical Director will lead the scientific design of interventional clinical studies, medical governance, and interpretation of results within the Medical Affairs organization (non-regulatory label-directed programs) for assigned asset(s)/indication(s). This role will partner closely with the GML and GMT and is the single point accountability for translating the evidence strategy set by the GMT into appropriate interventional studies. The study designed is expected to fulfill a strategic objective of the clinical development and integrated evidence plan. This role is pivotal in shaping data generation strategies and ensuring clinical trials are conducted with the highest standards of quality, ethics, and efficiency. The successful candidate will have deep expertise in industry-sponsored clinical research, global medical affairs, commercial acumen, and cross-functional team leadership. They will oversee multiple projects independently and may...

Biogen Director Analytics, Real World Evidence Strategy and Analytics About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating neurologic diseases. For more information please visit: www.biogen.com/careers Overview We have an exciting new opportunity for a Director Analytics, Real World Evidence Strategy and Analytics to join our team in Cambridge, MA. In this role you will lead a team of biostatisticians supporting post-approval retrospective and prospective observational studies. This role reports into the Head, Real World Evidence Strategy and Analytics within Medical Evidence and Outcomes Research (MEOR). Primary Responsibilities As Director Analytics, you will: Ensure that high quality biostatistical and pharmacoepidemiology support is provided...

CSL Are you ready to build the future product pipeline in a high-impact, strategic leadership role? The Senior Director of Medical Affairs, Cardiovascular & Renal (CVR) in Global Medical Affairs at CSL Vifor is responsible for the development and execution of global medical affairs strategies and tactics across the entire CVR Therapeutic Area (TA). These responsibilities are primarily focused on the pipeline and working closely with R&D and Commercial Strategy at the TA Leadership Team (TALT) membership level. This role works closely with regional and country teams to ensure global strategies and tactics are pulled through into the market and that impactful regional and country input from major markets are represented in global strategies. This role is also a key member of the CVR Therapeutic Area Leadership Team (TALT), and CSL Vifor Global Medical Affairs Leadership Team (MALT), contributing to the cross functional development of TA strategy and individual global...

Wespath Manager of Health Analytics and Strategy Location: 1901 Chestnut Ave Glenview, Illinois, 60025 United States Category: Benefit Plans Date Needed by: 7/25/2025 Recognized eight times as a Chicago's Best and Brightest Companies to Work For and seven times as a National Best and Brightest Companies to Work For, Wespath Benefits and Investments (Wespath) is seeking a talented individual to join our award-winning organization in the new role of Manager, Health Analytics and Strategy . Serving The United Methodist Church (UMC) for over a century; Wespath offers six HealthFlex medical plans that provide medical, prescription drug, behavioral health, dental, and vision care for over 40 plan sponsors, covering 15,000 lives. Our HealthFlex offering also includes a robust well-being program that aims to impact the physical, emotional, financial, social, and spiritual dimensions of our plan participant's lives. Wespath is an Equal Opportunity Employer that is...

Fusion Pharmaceuticals Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good...

GSK The Manufacturing Science and Technology (MSAT) organization is a site-based technical team responsible for ensuring manufacturing processes are capable, compliant and productive while maintaining product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported at the Rockville site and working with global MSAT implement process-related improvement programs across the product lifecycle. The Associate Director, Manufacturing Data Science serves as the site MSAT leader in the data and analytics space, supporting site initiatives and implementation of smart manufacturing principles in collaboration with the site digital and analytics teams and driving innovative solutions to complex technical problems. He or she will lead a team of data scientists and engineers to facilitate delivery of product and process data solutions in biologics manufacturing environment. This team will leverage data as a key asset...

Alkermes, Inc. We are seeking a highly motivated, strategic, and experienced neuroscience translational medicine expert to join as a key senior member of the Translational Medicine (TM) group in the Early Clinical Development line. This is an exciting, visible, and highly collaborative opportunity to apply your TM and broader R&D expertise and leadership skills toward achieving milestones for programs in neurology and psychiatry and influencing Alkermes' R&D strategy. The primary role for the Senior Director is to convert your expert TM strategic and tactical insight into scientific, actionable clinical plans and protocols to achieve program milestones and make data-driven decisions about molecules in development. Core responsibilities include designing and implementing clinical biomarker strategies for target engagement, PD response, and other contexts of use across programs and all Phases of clinical development; proactively integrating TM strategies with research,...

Manatt, Phelps & Phillips, LLP Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight, and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 270 attorneys and consultants from Manatt, Phelps & Phillips, LLP and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions, and lead healthcare into the future. For more information, visit https://www.manatt.com/Health . Position Overview : Manatt Health is seeking a highly qualified consultant with experience conducting quantitative analyses using Medicaid, Medicare and other claims data that is also interested in and capable of supporting...

Manatt, Phelps & Phillips, LLP Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight, and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 270 attorneys and consultants from Manatt, Phelps & Phillips, LLP and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions, and lead healthcare into the future. For more information, visit https://www.manatt.com/Health . Position Overview : Manatt Health is seeking a highly qualified consultant with experience conducting quantitative analyses using Medicaid, Medicare and other claims data that is also interested in and capable of supporting...

Manatt, Phelps & Phillips, LLP Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight, and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 270 attorneys and consultants from Manatt, Phelps & Phillips, LLP and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions, and lead healthcare into the future. For more information, visit https://www.manatt.com/Health . Position Overview: Manatt Health is seeking a highly qualified consultant with experience conducting quantitative analyses using Medicaid, Medicare and other claims data that is also interested in and capable of supporting...

Manatt, Phelps & Phillips, LLP Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight, and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 270 attorneys and consultants from Manatt, Phelps & Phillips, LLP and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions, and lead healthcare into the future. For more information, visit https://www.manatt.com/Health . Position Overview : Manatt Health is seeking a highly qualified consultant with experience conducting quantitative analyses using Medicaid, Medicare and other claims data that is also interested in and capable of supporting...