Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Director, Biostatistics - Remote Agios PharmaceuticalsDirector, Biostatistics - RemoteSan Diego, CARemote$183,000–$275,000 / yearThe current base salary range for this position is expected to be between $183,000 and $275,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Director will serve as the lead statistician for assigned clinical development programs, leading the development and implementation of statistical solutions to support all phases of clinical trials, regulatory filing and facilitating decision-making.
Head of Global Biostatistics Daiichi Sankyo, Inc.Head of Global BiostatisticsBasking Ridge, NJ$271,500–$452,500 / yearFull timeProvides regular status updates on projects, metrics and KPIs to Head of BDM and BDM LT External Vendor Oversight: Provides oversight of and is accountable for the quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. This role also serves as a key member of the BDM leadership team, contributing to BDM broader organizational strategy, cross-functional decision-making, and the advancement of BDM objectives beyond the Biostatistics function.
Senior Biostatistician Canfield Scientific, Inc.Senior BiostatisticianParsippany-Troy Hills, NJ$120,000–$160,000 / yearFull timeThe position requires strong technical expertise in statistics and SAS programming, with the ability to independently develop Statistical Analysis Plans (SAPs), execute and validate statistical analyses, and prepare statistical components of clinical study reports (CSRs). The right candidate can translate statistical outputs into clinically meaningful interpretations and communicate findings clearly to both technical and non-technical audiences.
Sr Biostatistician Medline IndustriesSr BiostatisticianWork From Home, IL$101,000–$152,000 / yearFull timeGenerate statistical analysis plan (SAP) including sample size calculations and randomization schedules, compile and clean raw data, conduct appropriate analysis per the SAP and interpret and present results. Build and sustain collaborative relationships with individuals in different disciplines and serves as subject-matter expert for research teams, internal and external clinical teams, and other collaborators.
NewBiostatistician JouléBiostatisticianJersey City, NJ$60–$65 / hourWe are seeking a detail-oriented and analytical Clinical Biostatistician (Consultant) to provide statistical support for clinical studies involving medical devices. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Associate Director Biostatistics Penfield Search PartnersAssociate Director BiostatisticsPrinceton, NJContribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches. Currently they are seeking an Associate Director of Biostatistics to support registration-directed clinical development programs and global regulatory submissions.
Virtual Biostatistician Hiring Event July 15th (PhD Statistics/Biostatistics) Medpace Holdings IncVirtual Biostatistician Hiring Event July 15th (PhD Statistics/Biostatistics)Cincinnati, OHContribute to clinical development of plan preparation; Review of study protocol and preparation of statistical methodologies; Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports; Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
Virtual Biostatistician Hiring Event - July 15th (PhD Statistics/Biostatistics) Medpace, Inc.Virtual Biostatistician Hiring Event - July 15th (PhD Statistics/Biostatistics)Cincinnati, OhioContribute to clinical development of plan preparation; Review of study protocol and preparation of statistical methodologies; Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports; Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
Associate Director, Biostatistics - Remote Penfield Search PartnersAssociate Director, Biostatistics - RemoteFairfield, CTRemoteThis role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results. You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy to support pursuant of precision medicine.
Director, Biostatistics Vor BioPharma IncDirector, BiostatisticsBoston, MA$230,000–$250,000 / yearReporting to the Head of Biometrics, this individual will serve as Vors global expert in biostatistical science, with accountability for all aspects of clinical trial design, statistical methodology, regulatory submission deliverables, and cross-functional scientific partnership. Regulatory Affairs & Submission Leadership • Author and review statistical sections of regulatory documents including INDs, investigator brochures, briefing books, CSRs, and eCTD/CTD module submissions to FDA, EMA, and other health authorities.
Senior Director Biostatistics - REMOTE Penfield Search PartnersSenior Director Biostatistics - REMOTERemote, RemoteRemoteThis role is ideal for an experienced biostatistics leader who thrives in a fast-paced biotech environment, enjoys working cross-functionally, and is comfortable rolling up their sleeves to support both strategic and operational activities. Reporting to senior clinical development leadership, this individual will serve as the lead statistician for clinical studies, providing expertise in trial design, statistical methodology, analysis planning, data interpretation, and regulatory submissions.
Associate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at Genmab Government of DenmarkAssociate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at GenmabPrinceton, NJAssociate Director, Biostatistics in Princeton, New Jersey, United States of America | Research & Discovery at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. Close Covid-19 banner Associate Director, Biostatistics Category Research & Discovery Job Id R15202 Remote This job available in 3 locations Princeton, New Jersey, United States of America Copenhagen, Capital, Denmark Utrecht, Netherlands Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases.
NewExecutive Director Biostatistics Lantheus Holdings IncExecutive Director BiostatisticsBedford, MA$206,000–$381,000 / yearThe Executive 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.
NewSenior Director, Biostatistics Bicycle Therapeutics PlcSenior Director, BiostatisticsLexington, MA$235,000–$295,000 / yearThe company is evaluating nuzafatide pevedotin (formerly 5528), a Bicycle Drug Conjugate (BDC) targeting EphA2, a historically undruggable target; zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Leadership / Mentorship: You develop future organisational leaders, providing coaching to senior statistical professionals and ensuring robust succession planning for your function.
Associate Director, Biostatistics Sun Pharmaceutical Industries LtdAssociate Director, BiostatisticsPrinceton, NJ$186,500–$207,000 / yearUse teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required. Reporting to a Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions.
Associate Director, Biostatistics Everest Clinical ResearchAssociate Director, BiostatisticsBridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Associate Director, Biostatistics (Statistical Operations) for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Review and provide input to clinical data management deliverables, including but not limited to the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan (DMP).
Sr. Director, Biostatistics Ipsen SASr. Director, BiostatisticsCambridge, MAIn 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.
Associate Director, Biostatistics - Genetic Medicine Regeneron Pharmaceuticals IncAssociate Director, Biostatistics - Genetic MedicineNY$176,100–$287,300 / yearIn this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
Assistant Professor - Department of Biostatistics Commonwealth of VirginiaAssistant Professor - Department of BiostatisticsRichmond, VAThis transformative funding will continue in Fall 2025 with the launch of CHRI 2.0, which will sustain and grow successful activities such as a visiting investigator program, an early research career development club, and provide statistical and pre- and post-award grant management as well as clinical regulatory and startup support for its awardees. The incoming faculty member will demonstrate the ability to communicate statistical concepts effectively to non- statistical audiences, collaborate on basic, translational, quality improvement and clinical projects, and serve as "statistical clinician" - focused on applied, impactful research rather than purely theoretical work.
Senior Director, Biostatistics Immunovant IncSenior Director, BiostatisticsNY$270,000–$310,000 / yearProvide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Senior Director, Biostatistics Sarepta Therapeutics IncSenior Director, BiostatisticsCambridge, MAFoster a culture where biostatisticians are hands-on analysts and scientific architects, not solely oversight managers, personally engaging with data exploration using modern tools (R, Python, interactive visualization) alongside traditional SAS workflows. The role requires a leader who can operate across both confirmatory and exploratory analytics - driving rigorous regulatory-grade deliverables while fostering a culture of rapid, hands-on data exploration in close partnership with clinical development.
Director, Biostatistics Sarepta Therapeutics IncDirector, BiostatisticsCambridge, MA$206,000–$257,500 / yearBeyond traditional SAP-driven deliverables, this role calls for a hands-on analyst who can explore data deeply, partner with clinical development to shape scientific questions, and deliver rapid insights using modern analytical tools. Leverage modern analytical tools (R, Python, interactive visualization apps) alongside SAS to accelerate data-to-insight timelines, while maintaining clear documentation and traceability of exploratory work.
Director, Biostatistics KaztronixDirector, BiostatisticsMiami, FLRemoteKey Responsibilities: " Provide statistical leadership and support across all clinical development functions and lead all assigned projects within the Biometrics department. " Participate and interact with clinical and cross-functional teams in the development of protocols, study design, and endpoints discussions.
Tenure-Track Biostatistics Faculty Temple UniversityTenure-Track Biostatistics FacultyPhiladelphia, PennsylvaniaThe Department has 15 full-time faculty with expertise in mediation, causal inference, missing data and measurement error, semiparametric regression, latent variable modeling, and psychometrics as well as behavioral and chronic disease epidemiology, cancer prevention and control, environmental and occupational exposures, seroepidemiology and disease modeling, aging and cognitive decline, and cardiovascular disease. The Department annually enrolls over 1,800 undergraduate and graduate students with diverse backgrounds and administers five graduate programs: PhD in Epidemiology; MPH degrees in Epidemiology (in-person and online), Applied Biostatistics, and Environmental Health; and MS in Public Health Data Science.
Biostatistics Associate Director (HYBRID) Vertex Pharmaceuticals IncBiostatistics Associate Director (HYBRID)Boston, MA$174,800–$262,200 / yearGeneral Summary: Biostatistics Associate Director will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
Director, Biostatistics Monte Rosa Therapeutics, IncDirector, BiostatisticsBoston, MassachusettsFull timeThe Director will work closely with Clinical Development and external partners to drive trial design, analysis strategies, and regulatory‑ready outputs while remaining directly involved in study‑level statistical activities. Overview: The Director of Biostatistics is a hands‑on statistical leader responsible for the design, analysis, and interpretation of Phase 1–Phase 3 clinical trials with a primary focus on inflammation and oncology indications.
Executive Director Biostatistics Alnylam Pharmaceuticals IncExecutive Director BiostatisticsCambridge, MA$301,800–$408,200 / yearLead the development and implementation of statistical strategies across programs including clinical trial designs, endpoint strategies, and regulatory strategies, partnering with Clinical Development and cross-functional leaders to shape development plans. The Executive Director leads a team of statisticians and works closely with cross‑functional leaders to ensure rigorous and innovative quantitative approaches to drug development.
Postdoctoral Fellow - Biostatistics University of Texas MD Anderson Cancer CenterPostdoctoral Fellow - BiostatisticsHouston, TX$64,000–$76,000 / yearThe primary research area can encompass: (i) developing and applying novel statistical and computational methods for the analysis of omics data from various sources, such as high-throughput proteomic, genomic, sequencing, transcriptomic, and imaging data, with particular emphasis on developing integrative and flexible models that incorporate both biological knowledge and empirical structures; and (ii) developing novel statistical and machine learning methods for the analysis of proteomics data with focuses on cancer research. The candidate will learn on areas include statistical theory and application in cancer proteomics/genomics; Obtain expertise in the integration of metabolites and proteins for early detection and risk assessment of cancer; Gain experience in cutting-edge analysis of "big data" and novel machine learning algorithms; Acquire extensive experience in R, R-Shiny, Python, and other programming languages/environments.
Biostatistics Associate Director Vertex Pharmaceuticals IncBiostatistics Associate DirectorBoston, MA$236,000–$354,000 / yearGeneral Summary: The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. 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.
Associate Director Biostatistics Alnylam Pharmaceuticals IncAssociate Director BiostatisticsCambridge, MA$185,300–$250,700 / yearThe Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.
Director Biostatistics Alnylam Pharmaceuticals IncDirector BiostatisticsCambridge, MA$212,500–$287,500 / yearHe/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.
Exec Director, Head of Biostatistics, Biometric Sciences Viridian Therapeutics IncExec Director, Head of Biostatistics, Biometric SciencesWaltham, MAResponsibilities (including, but not limited to): Ensure that Company Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and life cycle management of existing products. Reporting to the SVP, Head of Biometric Sciences, the Executive Director will be responsible for managing biostatistical activities across multiple studies and programs from study start-up through study closure to ensure completion per established project team goals and objectives.
Executive Director, Biostatistics Vertex Pharmaceuticals IncExecutive Director, BiostatisticsBoston, MA$236,000–$354,000 / yearOversees, manages, and directs multiple key projects, providing both strategic and technical expertise, and including clinical trials, observational studies, real world data (RWD) investigations, or other scientific research. General Summary: The Senior Director, Biostatistics will independently perform highly scientific statistical functions in support of a company therapeutic area or areas on new and complex issues.
OPEN RANK: Assistant to Associate Professor in Biostatistics University of Maryland School of MedicineOPEN RANK: Assistant to Associate Professor in BiostatisticsBaltimore, MD$110,000–$228,000 / yearJob Description - OPEN RANK: Assistant to Associate Professor in Biostatistics (260000B2) Job Description OPEN RANK: Assistant to Associate Professor in Biostatistics - (260000B2) Job Number/Taleo: 260000B2 FRIS: 03-307-181 FRIS: 03-307-182 OPEN RANK: Assistant to Associate Professor in Biostatistics The Division of Biostatistics and Bioinformatics within the Department of Epidemiology and Public Health (EPH) at the University of Maryland School of Medicine is recruiting two full-time, non-tenure track/tenure track Assistant or Associate Professor with interests in analysis with real-world data, high-dimensional data, causal inference, innovative clinical trials analysis, and/or machine learning (ML)/artificial intelligence (AI) to join our thriving research environment. The Division of Biostatistics and Bioinformatics hosts multidisciplinary research projects that span topics such as hip fracture recovery, cognitive functioning and dementia, vaccine efficacy and effectiveness, mental health interventions, target trial emulation, neuroimaging, -omics data analysis and coordination, transportation statistics, and administrative claims and electronic health record data analysis.
Deputy Director - Senior Project Biostatistics Lead- Vaccines SanofiDeputy Director - Senior Project Biostatistics Lead- VaccinesSwiftwater, PA$148.50–$214.50 / hourAs Deputy Director - Senior Project Biostatistics Lead - Vaccines within our R&D team, you will serve as a Senior Biostatistics Expert at the vaccine project level, playing a critical role in developing end-to-end clinical development plans and contributing to the advancement of life-saving vaccines. Additionally, you will communicate trial results internally, work cross-functionally on scientific interpretation and strategic impact evaluation, contribute to external communication of study results to Health Authorities, and be accountable for the statistical aspects of submissions for marketing authorization or label improvement.
Lecturer on Biostatistics Harvard UniversityLecturer on BiostatisticsCambridge, MA$135,000–$155,000 / yearOur 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.
Senior Director, Biostatistics Perspective TherapeuticsSenior Director, BiostatisticsUnited StatesFull timeReporting to the Chief Medical Officer, the Senior Director, Biostatistics, provides strategic and operational leadership for an established biostatistics function supporting the design, analysis, evaluation, and reporting of clinical trials. The role is accountable for overseeing end-to-end clinical data workflows, ensuring the high-quality evaluation of clinical data, and maintaining robust systems and processes to support efficient trial execution.
Postdoctoral Research Associate - Biostatistics St. Jude Children's Research Hospital IncPostdoctoral Research Associate - BiostatisticsMemphis, TNAll resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Job Posting Description: St. Jude is seeking an outstanding candidate for a postdoctoral fellowship in biostatistics methods and applications involving pediatric cancer and catastrophic diseases.
Director, Biostatistics Definium Therapeutics IncDirector, BiostatisticsBoston, MA$224,643–$249,312 / yearReporting to Vice President, Head of Biometrics and Data Science, this role will serve as the lead biostatistician for the assigned clinical programs and/or clinical studies, providing statistical leadership from clinical trial design, data analysis - covering planning and execution - to results interpretation and dissemination. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder.
Senior Director Biostatistics Madrigal PharmaceuticalsSenior Director BiostatisticsPennsylvaniaPlease know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Senior Manager, Biostatistics Axsome Therapeutics IncSenior Manager, BiostatisticsNYRemote$140,000–$170,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Reporting to the Senior Director, Biostatistics, the Senior Manager, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs).
Senior Director, Biostatistics Premier Research International LLCSenior Director, BiostatisticsDevelop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
Sr. Director, Biostatistics Atavistik Bio IncSr. Director, BiostatisticsCambridge, MA$270,000–$290,000 / yearAtavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. Oversee and lead the vendor/CRO biostatistics and programming teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks.
Associate Director, Biostatistics Clinical Dynamix, Inc.Associate Director, BiostatisticsBurlington, MAspecific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and. •Provide high-quality statistical support across clinical programs, ensuring scientific.
Manager, Biostatistics - Medical Affairs Regeneron PharmaceuticalsManager, Biostatistics - Medical AffairsTogether with medical directors, HEOR, medical writing, market access, and other colleagues within medical affairs, you will plan and execute evidence generation efforts, such as post-hoc analysis with innovative analytical approaches, respond to payer and reimbursement needs, review investigator initiated studies, and design and execute Phase IV studies as the study biostatistician, and ensure statistical rigor in all these duties. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen, and excellent communication and interpersonal skills.
Postdoctoral Research Associate in the Department of Biostatistics & Health Data Science Lehigh UniversityPostdoctoral Research Associate in the Department of Biostatistics & Health Data ScienceBethlehem, PAShe is an Assistant Professor jointly appointed in Civil & Environmental Engineering and Population Health at Lehigh University, where her work includes sustained engagement with water, sanitation, and hygiene (WASH) challenges in humanitarian and development contexts, which serve as important contexts for broader questions about environmental transmission, system resilience, and the real-world performance of public health interventions. Areas of expertise include bioinformatics, computational biology, artificial intelligence, network science, Bayesian methods, spatiotemporal methods, visualization, evolutionary game theory, infectious disease modeling, and assistive and accessibility technologies, with a shared commitment to improving health outcomes through data-driven discovery.
ASSOCIATE DIRECTOR, BIOSTATISTICS DCRI Duke UniversityASSOCIATE DIRECTOR, BIOSTATISTICS DCRIDurham, NCSharing Knowledge and Serving as Resource • Serve as an expert on internal or external groups to develop policies or guidance documents related to the product line • From time to time, serve as thought leader and provide expertise for research projects conducted by DCRI • Related to product line, develop educational materials, conduct educational programs, and provide mentorship for others, including internal staff and external groups such as pharmaceutical companies and other academic centers, non-statistical staff at the DCRI, and web-based seminars • Serves as a resource within the department on guidelines from the FDA, ICH, EMEA, IRBs, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data related to area of product focus • Shares solid understanding of clinical research and the clinical drug and/or device development process and maintains this evolving knowledge base into the future. Business Development • Lead development and enhancements of the Interventional Biostatistics product line within Biostatistics • Provide consultation and assistance as needed to assist in recruitment and budgeting of new DCRI trial/projects • Represent the Biostatistics group in internal and external business development meetings, including presentations about the capabilities and operations of the Biostatistics group, for external clients in the pharmaceutical, medical device, biotechnology, or regulatory community • Raise internal awareness and understanding within DCRI faculty and staff of product line(s) and value to the DCRI • Develop and/or provide input into marketing materials (slide presentations, brochures, website materials) regarding statistical capabilities and services related to product line • Consult with Business Development to provide advice regarding the practicality and appropriateness of potential projects.
NewDirector/Senior Director, Biostatistics Lakefront Biotherapeutics NVDirector/Senior Director, BiostatisticsSan Francisco, CA$230,000–$300,000 / yearThis is a highly visible, cross-functional role in which you will own the statistical strategy for our clinical programs - from designing statistical strategy through data analysis, interpretation of results, and regulatory submission. Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need.