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Reporting to the Vice President, Head of Biostatistics & Statistical Programming, this individual will serve as a hands-on statistical lead for assigned studies or program activities, partnering across clinical, regulatory, safety, data management, and programming teams to support robust study design, high-quality analyses, and clear interpretation of results. Responsibilities and Duties Serve as the statistical lead for assigned clinical studies or defined program activities, contributing to clinical development plans, study design, sample size and power calculations, protocols, statistical analysis plans (SAPs), TLFs, data analyses, and interpretation of results.

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Rhythm Pharmaceuticals

Associate Director, Biostatistics

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This position will involve collaborative interactions with Hollings Cancer Center faculty with an emphasis on joint grant proposals, design and conduct of early phase clinical trials, development of statistical methodology to advance cancer research, and the design of laboratory, clinical and epidemiologic studies. Job Description: The Hollings Cancer Center and the Department of Public Health Sciences at the Medical University of South Carolina (MUSC) invite applications for Research Assistant or Research Associate Professor of Biostatistics.

Medical University of South Carolina

UNIV - Research Faculty of Biostatistics - Open Rank - Department of PHS

This position will involve collaborative interactions with Hollings Cancer Center faculty with an emphasis on joint grant proposals, design and conduct of early phase clinical trials, development of statistical methodology to advance cancer research, and the design of laboratory, clinical and epidemiologic studies. Interested applicants should send a cover letter describing qualifications – especially current and past collaborative experiences – and curriculum vitae to HCC BSR Search Committee c/o Elizabeth Hill (hille@musc.edu).

MUSC

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Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. You will be an integrated member of the Relay Tx clinical development team, responsible for the in-house biostatistics expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients.

Relay Therapeutics

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The ideal candidate is an experienced biostatistics professional with deep expertise in small molecule drug development, a proven track record of leading teams across multiple therapeutic areas, and the ability to operate in a fast-paced, innovative environment. This individual will work collaboratively with cross-functional teams to ensure the delivery of high-quality statistical and data management support, driving clinical programs toward successful trial design and execution as well as regulatory submissions and commercialization.

Enveda

VP, Clinical Biostatistics

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Roivant's pipeline includes LISRAYA (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.

Pulmovant Inc

Director, Biostatistics, Pulmovant

This leader will be an embedded, working member of the cross-functional program team—alongside Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Translational Medicine and Program Management—authoring and owning statistical analysis plans, defining estimands, performing analyses and driving the statistical content of protocols, health-authority interactions and scientific presentations. Reporting to the VP, Program Management and Head of Clinical Trial Services, the Senior Director / Executive Director, Biostatistics will lead the biostatistics strategy for the NKX019 autoimmune program—from ongoing multi-indication Phase 1/2 studies through potential pivotal trial design—and will be Nkarta's most senior statistical voice with the FDA, the Board, investigators, partners and the scientific community.

Nkarta, Inc.

Senior Director/Executive Director, Biostatistics

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Successful applicants will have expertise in protocol development, proficiency in clinical trial electronic database development using REDCap and fluency with NIH Common Data Elements, experience with trial conduct including risk-based monitoring and reporting, and familiarity with ICH Efficacy Guidelines for Good Clinical Practice (ICH E6) and Statistical Principles for Clinical Trials (ICH E9). This position will involve significant collaborative interactions with Hollings Cancer Center clinical researchers with a major emphasis on the design and conduct of early phase oncology therapeutic trials and non-therapeutic behavioral or hybrid efficacy-implementation trials.

UNIV - Research Instructor of Biostatistics - Department of PHS

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. The Director, Biostatistics will be working in a cross functional team, responsible for providing program and project-level statistical expertise and leadership in the development of Ipsen neuroscience assets.

Ipsen SA

Director, Biostatistics

Roivant’s pipeline includes LISRAYA (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. .

Pulmovant

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.

Senior Director, Biostatistics Rare Diseases

All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut. As DCRI expands its capabilities in biostatistics, biomedical informatics, and data science, this role offers a unique opportunity to help shape the future scope of clinical research-moving beyond traditional Phase II/III trial support to advance innovative, pragmatic research and AI-enabled discovery.

Duke University

Associate Director, Biostatistics Dcri

Enveda Biosciences Inc

ImCheck Therapeutics SAS

Acting as indication Biostatistics Lead, your role is crucial in the clinical development and evidence generation strategy and execution, providing direction, oversight and/or direct contributions as appropriate on clinical development plans, protocols and analysis, clinical study reports and regulatory submission materials, and ensures the adherence to regulatory guidelines and scientific rigor. The Director will coach and supervise statisticians working on the projects, build and maintain strong collaboration with key stakeholders from different disciplines across the organization, and represent Biostatistics on cross-functional teams, in meetings with governance committee, regulatory agencies, advisory boards as appropriate.

Biogen

Director, Biostatistics, WCH

Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Key Responsibilities: Drive statistical execution for assigned programs, providing critical input on study design, protocol development, and statistical analysis planning while collaborating closely with cross-functional study teams.

Oruka Therapeutics Inc

This individual will serve as the lead biostatistician for one or more clinical development programs and will partner closely with Clinical Development, Medical Affairs, Data Management, Statistical Programming, Regulatory Affairs, and external partners to ensure the delivery of high-quality statistical strategy, analyses, and regulatory submissions. The successful candidate will contribute to study design, protocol development, analysis planning, interpretation of clinical data, regulatory interactions, and evidence generation activities that support development, registration, and lifecycle management of Avalo's programs.

Avalo Therapeutics

Sr. Manager/ Associate Director, Biostatistics

Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. You will be an integrated member of the Relay Tx clinical development team, responsible for the in-house biostatistics expertise for the execution of clinical studies that will translate Relay's innovative science into impactful medicines for patients.

Biostatistician Jobs in the United States

Associate Director, Biostatistics Rhythm Pharmaceuticals

UNIV - Research Faculty of Biostatistics - Open Rank - Department of PHS Medical University of South Carolina

UNIV - Research Faculty of Biostatistics - Open Rank - Department of PHS MUSC

Associate Director, Biostatistics Relay Therapeutics

VP, Clinical Biostatistics Enveda

Director, Biostatistics, Pulmovant Pulmovant Inc

Senior Director/Executive Director, Biostatistics Nkarta, Inc.

UNIV - Research Instructor of Biostatistics - Department of PHS MUSC

Director, Biostatistics Ipsen SA

Director, Biostatistics, Pulmovant Pulmovant

Senior Director, Biostatistics Rare Diseases Ipsen SA

Associate Director, Biostatistics Dcri Duke University

VP, Clinical Biostatistics Enveda Biosciences Inc

Director, Biostatistics ImCheck Therapeutics SAS

Director, Biostatistics, WCH Biogen

Associate Director, Biostatistics Oruka Therapeutics Inc

Senior Director, Biostatistics Rare Diseases ImCheck Therapeutics SAS

Sr. Manager/ Associate Director, Biostatistics Avalo Therapeutics

Associate Director, Biostatistics Relay Therapeutics, Inc.

Director, Biostatistics Ipsen

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