div>Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
Watertown, MA30+ days ago
Reporting to the Chief Medical Officer, you will provide executive leadership across biostatistics activities, with an initial focus on REM-422, our lead asset. Serve as a core representative in cross-functional meetings, aligning biostatistics strategy with clinical development, regulatory affairs, and quality assurance.
Provide statistical support on one or more assets or indications by directing the execution of statistical analyses, review of statistical outputs, and ensuring accurate results interpretation, collaborating closely with physicians, evidence generation stakeholders, or other cross-functional leads as appropriate on the interpretation of clinical results. Provide guidance to the clinical, regulatory, and/or evidence generation teams on conclusions and inferences from the data package, ensuring statistical perspective is integrated into regulatory and external meetings, and delivering data packages aligned with submission requirements or key decision-making.
This role ensures statistical rigor and integrity of Health Technology Assessment (HTA), real-world evidence (RWE), Medical Affairs and HEOR studies, and publications, and provides high-quality clinical evidence inputs to health economic evaluations and payer submissions. As a member of the Global Biometrics Department, the Senior Manager, Biostatistics supports the development and implementation of robust statistical strategies for Medical Affairs and Health Economics & Outcomes Research (HEOR) initiatives for one or more oncology products.
Boston, Massachusetts30+ days ago
p style="text-align:inherit"/>At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Mentor statisticians, promote knowledge sharing, and, as the function grows, build and lead a statistical innovation and methodology team to strengthen methodological expertise and foster a culture of statistical innovation within the Biostatistics organization. Engage externally with scientific organizations, regulatory agencies, and academic collaborators to contribute to methodological advancement, inform industry best practices, and ensure awareness of emerging statistical approaches.
p>Reporting to the Executive Director, Biostatistics, Biometric Sciences, the Senior Director of Biostatistics, Biometric Sciences will be involved in the design, execution, analysis, and reporting clinical studies across Viridian's development programs that are leveraging our cutting-edge Monoclonal antibody science to create transformative medicines for patients. Responsibilities (including, but not limited to):
- Serve as the biostatistics leader & partner to our clinical development team responsible for determining clinical study strategies and manage junior staff to deliver results with high quality and on time.
Marlborough, MA21 days ago
p>Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. Knowledge, Skills and Abilities (general & technical):
- Leadership and Management: Demonstrated capability to lead and mentor teams, manage multiple projects simultaneously, and drive results in a fast-paced environment.
p>Salary Range: CHI: $180,000-$240,000 USD NYC/SF: $190,000-$260,000 The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). We are seeking a highly motivated and capable Director of Biostatistics to lead a team of biostatisticians involved in multiple aspects of clinical research at Tempus.
In addition, she/he will have the capacity to understand relevant multi-disciplinary knowledge and interact effectively with within the biometrics department with clinicians, regulatory affairs, medical writing, clinical operations, service/technology providers, as well data management and statistical programming. Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
p>In this new role, reporting to the Vice President, Biometrics you will be working with cross‑functional clinical teams responsible for statistical activities across Tango's clinical programs, including overseeing statistical deliverables outsourced to clinical CROs. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
Cambridge, MA30+ days ago
This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines.
p>The Senior Director will serve as the project-level biostatistician, providing expertise in the development and execution of statistical strategies, study designs, statistical analyses, and regulatory submissions for clinical development across various therapeutic areas. He/she will collaborate closely with clinical science, regulatory, and other cross-functional teams to develop clinical development plans, author key clinical, regulatory, and statistical documents, and ensure the high-quality delivery and interpretation of clinical data.
Our faculty are leaders in the development of methods for the design and analysis of clinical trials and observational studies, missing data, causal inference, precision health, network analysis, computational and systems biology, microbiome analysis, statistical genetics and genomics, mental health, statistical and machine learning methods, and environmental biostatistics. The Lecturer will develop and continuously update course materials to reflect evolving methods and best practices, play an active role in coordinating instruction across the Department of Biostatistics master's programs, and contribute to educational program administration including curriculum planning and pedagogical innovation.
Boston, Massachusetts9 days ago
div>Accountabilities for supporting projects directly include:
Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities .
The Associate Director, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project.
Boston, Massachusetts14 days ago
div>The Director, Biostatistics has sufficient experience in the pharmaceutical industry to independently lead a biostatistics team to deliver project and/or technical level activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions.
This role will be responsible for overseeing statistical activities for multiple clinical studies within a clinical development program, serve as a key contributor to study design and protocol development, and conceptualizing and performing analyses of clinical trial data. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics.
In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
Prepare abstracts, posters, oral presentations, and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge. We specialize in strategic global partnering, in-licensing and developing, manufacturing, and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.