Director of Biostatistics - Early Phase

We are seeking a talented and driven Associate Director of Biostatistics to join our innovative team at Definium Therapeutics. In this pivotal role, you will lead biostatistical efforts in the design, analysis, and interpretation of clinical trials, ensuring that our research meets the highest standards of scientific rigor.

About Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a dynamic, well-funded biotechnology firm listed on Nasdaq. We provide an exciting opportunity to work in a fast-paced environment where you can influence our company culture and take on diverse responsibilities to foster your professional growth.As a clinical-stage biotechnology company, we are pioneering novel biologics aimed at transforming treatment options in the largest Inflammation & Immunology (I&I) markets. Our antibody programs are meticulously designed to address the shortcomings of existing therapies by targeting established mechanisms of action while incorporating advanced engineering to enhance efficacy and dosing. Our lead program, Zumilokibart (APG777), focuses on treating atopic dermatitis and asthma, two areas with significant unmet needs. With a robust pipeline and a strong leadership team, Apogee is dedicated to delivering exceptional value and benefits to patients who are underserved by current standards of care.We pride ourselves on our vibrant culture rooted in our C.O.R.E. values: Caring, Original, Resilient, and Egoless, with a steadfast commitment to excellence.If this resonates with you, we invite you to explore further!Role SummaryWe are on the lookout for an Associate Director of Biostatistics to assume a pivotal role as the statistical lead for one or multiple projects. In this capacity, you will provide technical leadership and statistical support throughout study design, project planning, and execution of clinical studies, including scientific publications. You will collaborate closely with cross-functional teams, delivering expert biostatistical insights into development plans, regulatory interactions, and study design. Key responsibilities may include authoring and reviewing the statistics sections in protocols, determining sample sizes, authoring and reviewing statistical analysis plans and mock tables, analyzing and interpreting clinical study results, and ensuring the integrity of statistical methodologies.

About Us Kardigan is a pioneering heart health company dedicated to transforming cardiovascular disease into a preventable, treatable condition, aiming to eliminate it as the leading cause of death globally.Our mission is to develop a diverse range of targeted treatments concurrently that will lead to the cures our patients with cardiovascular diseases deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s founders have reunited following their success at MyoKardia, where they facilitated the discovery and development of mavacamten, the first cardiac myosin inhibitor, culminating in the acquisition by Bristol Myers Squibb in 2020. We boast a cutting-edge discovery and translational research platform, a pipeline full of late-stage candidates, and an exceptional team devoted to enhancing patient lives. At Kardigan, our values drive our work, interactions, and achievements. We are patient-centered, fiercely committed to improving lives and prioritizing patient needs. We believe in authenticity, fostering an environment of acceptance through honest leadership. With a curiosity-driven mindset, we encourage innovative thinking and adaptability. We strive for team success, supporting one another in our collective mission with urgency and excellence. Finally, we aim to enable the impossible, taking calculated risks to inspire innovation and advance scientific breakthroughs. Our core values empower us daily to make a significant impact. Position Title: Associate Director (AD), BiostatisticsDepartment: Development - Data ScienceReports To: Director, BiostatisticsLocation: South San Francisco, CA or Princeton, NJ

Revolution Medicines, Inc. seeks an Associate Director, Biostatistics to guide statistical planning and analysis for early-phase clinical trials. Based in Redwood City, California, this position shapes the statistical approach for studies aimed at developing new cancer treatments. Role overview This position leads the design and execution of statistical strategies for early-stage clinical programs. The Associate Director works closely with cross-functional teams to ensure that data from clinical trials is accurate and reliable, supporting the company’s research goals in oncology. Key responsibilities Develop and oversee statistical analysis plans for early-phase clinical studies. Ensure data quality, integrity, and accuracy throughout the clinical development process. Contribute to advancing new cancer therapies by providing statistical expertise. Location This role is based in Redwood City, California.

At Alumis Inc., we are passionate about revolutionizing the treatment landscape for individuals suffering from autoimmune diseases. Our commitment to precision medicine drives us to innovate treatments that significantly enhance patient outcomes, addressing the unmet needs of those living with immunologic conditions.We are currently in search of an experienced Associate Director of Biostatistics to lend their statistical acumen and operational support to both early-stage and late-stage clinical programs. This pivotal role will see you acting as the lead statistician for various studies, collaborating with multidisciplinary teams to facilitate clinical development and informed decision-making through data analysis. You will play an active role in critical deliverables, oversee CRO activities, and mentor junior team members, fostering a culture of excellence within our statistical team.

Role overview Natera is hiring an Associate Director of Biostatistics to join the team in San Carlos, CA. This leadership position oversees a group of biostatisticians and partners with colleagues from multiple departments. The main focus is on designing and analyzing clinical trials that support projects in genomic testing and personalized medicine. What you will do Supervise and mentor a team of biostatisticians Work with cross-functional teams to plan and analyze clinical trials Use statistical programming and analysis methods in healthcare research Contribute statistical data for regulatory submissions Impact This position plays a key role in advancing genomic testing and personalized medicine. The work aims to improve patient care by providing data-driven insights that inform healthcare decisions.

Eikon Therapeutics is an innovative biopharmaceutical company harnessing cutting-edge technology at the crossroads of chemistry, engineering, computation, and biology to develop groundbreaking treatments for critical health conditions. Our discovery platform is founded on transformative innovations from our Nobel Prize-winning founders (2014), leading to the development of advanced microscopes that facilitate real-time, molecular-resolution observations of protein dynamics in living cells. This approach opens new avenues in targeting previously untouchable classes of proteins for drug development.Position OverviewWe are on the lookout for a talented and driven Associate Director of Biostatistics to enhance our dynamic team. The successful candidate will leverage their statistical knowledge and strategic acumen to oversee the design, implementation, and analysis of clinical trials and experimental studies. Working in close collaboration with cross-functional teams, you will spearhead statistical initiatives that underpin data-driven conclusions and inform our research and development strategies.This position necessitates a minimum of three days per week on-site presence in our New Jersey office to ensure effective leadership, operational excellence, and high-quality execution of clinical studies while supporting the anticipated significant team growth and collaboration.Your ProfileThe ideal candidate will have a proven history of designing and analyzing clinical trials and experimental research, particularly within the biotechnology, pharmaceutical, or allied sectors. This individual excels in leading interdisciplinary teams to formulate study designs, develop statistical analysis plans, perform advanced statistical evaluations, and mentor team members. Expertise in statistical programming languages, a thorough understanding of regulatory requirements, and outstanding communication skills are crucial for articulating complex statistical concepts to non-technical audiences. The perfect candidate will also demonstrate strong leadership skills and a comprehensive understanding of the latest trends and best practices in biostatistics, statistical tools, and software.

Eikon Therapeutics develops new treatments for life-threatening diseases by combining chemistry, engineering, computation, and biology. The company’s discovery platform draws on innovations from its founders, including a 2014 Nobel Prize winner, and features advanced microscopes that measure protein dynamics in living cells at molecular resolution. This technology enables drug discovery for protein classes that were previously out of reach. Role Overview The Associate Director of Biostatistics will guide statistical strategy and execution for clinical trials and experimental studies. This leader will work closely with cross-functional teams to design studies, implement statistical methods, and interpret results that support research and development. The role is based in Jersey City, NJ, and requires at least three days per week on site, with flexibility to increase as business needs grow and the team expands. What You Will Do Design and analyze clinical trials and experimental studies Lead interdisciplinary teams in study design and statistical planning Develop and review statistical analysis plans Conduct advanced statistical analyses Mentor and support team members in statistical methods and best practices Collaborate with other departments to ensure statistical rigor in research What We Look For Experience designing and analyzing clinical trials or experimental studies in biotechnology, pharmaceuticals, or related fields Strong leadership skills and experience guiding interdisciplinary teams Proficiency in statistical programming languages Knowledge of regulatory standards relevant to clinical research Clear communication skills, especially when explaining statistical concepts to non-technical colleagues Awareness of current trends, tools, and best practices in biostatistics Location and On-Site Requirement This position is based in Jersey City, NJ. A minimum of three days per week on site is required, with flexibility to adjust as team and business needs evolve.

Bicycle Therapeutics is seeking a Senior Director of Biostatistics to guide its biostatistics team in Lexington. This leadership role centers on advancing the development of new therapies through strong statistical oversight and collaboration. Role overview The Senior Director of Biostatistics leads the team responsible for statistical analysis across projects. The position requires careful attention to data integrity and a commitment to meeting regulatory standards. Working closely with colleagues from various disciplines, this leader plays a key part in moving therapeutic programs ahead. Key responsibilities Oversee statistical analysis for clinical and research projects Maintain high standards of data integrity Ensure compliance with regulatory requirements Collaborate with cross-functional teams to support project goals Location This position is based in Lexington.

About Fulcrum Therapeutics Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a clinical-stage biopharmaceutical company based in Cambridge, MA. The team focuses on developing small molecule therapies for genetically defined rare diseases, with an emphasis on areas where patients have limited treatment options. The lead program, Pociredir, aims to increase fetal hemoglobin expression as a novel approach for treating sickle cell disease (SCD). Role Summary: Director of Biostatistics The Director of Biostatistics plays a key role within the Biometrics Department and reports to the VP of Biometrics. This position acts as the statistical subject matter expert for Fulcrum’s clinical development programs and individual studies. The director oversees statistical activities for outsourced clinical trials and ensures all work meets regulatory requirements. Main Responsibilities Serve as the lead statistician for clinical development programs and studies Oversee statistical activities in outsourced clinical trials Ensure compliance with regulatory standards in all statistical work Apply advanced study designs and statistical methods, including estimand strategies, endpoint selection, and approaches for missing data and multiplicity Work closely with teams across biometrics, clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs

The PositionAs the Director of Biostatistics at Maze Therapeutics, you will be pivotal in guiding the clinical advancement of our innovative therapeutic programs. This role involves close collaboration with teams in Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science, ensuring our clinical studies are methodologically sound, data-driven, and impactful.You will be responsible for the biostatistical strategy and execution, overseeing the entire process from study design to regulatory submissions, seamlessly blending hands-on expertise with strategic oversight. Your role will include representing the Biostatistics function in clinical study teams, guiding the interpretation of intricate data, and managing CRO partnerships to guarantee the delivery of high-quality statistical outputs.This position reports directly to the Vice President of Biometrics.Your ImpactLead biostatistical efforts for clinical studies, offering expert insights on study design, endpoints, and statistical methodologies.Oversee the completion of all technical and operational statistical tasks for a portfolio of clinical trials, ensuring the development and review of complex and innovative statistical analysis plans (SAPs).Work collaboratively with cross-functional teams on protocol development, study design discussions, and data interpretation.Partner with Statistical Programming to develop and validate analyses for internal purposes, publications, and regulatory submissions.Supervise CRO execution of statistical tasks, ensuring adherence to timelines, quality standards, and analytical approaches.Represent the Biostatistics department in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparations, and responses to agency inquiries.Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA).Utilize advanced statistical techniques to analyze and interpret clinical, safety, biomarker, and exploratory data.Advise internal and external stakeholders on statistical methodologies, data integrity, model selection, and result interpretation.Lead the integration and analysis of diverse data sources to facilitate the delivery of special projects and statistical analysis plans for assigned products.Review and assess safety reports, biomarker analyses, and other elements of clinical trial monitoring.Enhance statistical software as needed by programming new techniques; stay updated on current and emerging trends in statistical analysis methodologies and tools.Provide biostatistical input into clinical development documentation and scientific publications.

About Formation BioFormation Bio is a pioneering pharmaceutical company harnessing technology and artificial intelligence to transform drug development efficiency. The rapid advancements in AI and drug discovery are generating a plethora of candidate drugs, yet the high costs and lengthy timelines associated with clinical trials pose significant challenges. Acknowledging this bottleneck that could restrict the availability of new medicines to patients, Formation Bio, established in 2016 as TrialSpark Inc., has developed innovative technology platforms, processes, and capabilities designed to expedite drug development and clinical trials. Our company actively partners with, acquires, or in-licenses drugs from pharmaceutical firms, research organizations, and biotech companies to advance programs beyond clinical proof of concept, ultimately facilitating the introduction of new treatments to patients. Our esteemed investor base includes prominent names from both the pharmaceutical and tech sectors such as a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, and SV Angel Growth. Explore more about us at the following links:Our Vision for AI in PharmaOur Current Drug PortfolioOur Technology & PlatformAt Formation Bio, our core values drive our mission to innovate the pharmaceutical industry. Every team member embodies these values, contributing significantly to our goal of delivering new treatments to patients more swiftly and efficiently.About the PositionFormation Bio is in search of a highly qualified and seasoned Senior Director of Biostatistics to become part of our dynamic team. This pivotal role will report directly to the Head of Biometrics, overseeing the development of the biostatistics team and strategy, spearheading impactful statistical initiatives, and leveraging biostatistics to enhance our drug development processes.The Senior Director of Biostatistics will be instrumental in designing innovative trial frameworks, supporting regulatory strategies, and ensuring exceptional statistical contributions throughout clinical development. The role also entails cross-functional collaboration to integrate advanced analytics, data-driven decision-making, and AI applications into our development programs to boost efficiency and increase the probability of success.

ABOUT USAt Invivyd, Inc., we are dedicated to protecting over 9 million immunocompromised individuals in the United States, including those at the highest risk for severe COVID-19. Our mission is to innovate in the field of viral infectious diseases, starting with SARS-CoV-2. We utilize a proprietary integrated technology platform that is unparalleled in the industry to assess, monitor, and develop top-tier antibodies.Recent Achievements:In March 2024, we received emergency use authorization (EUA) from the U.S. FDA for one of our monoclonal antibody (mAb) candidates. Subsequently, in October 2025, our Investigational New Drug (IND) application was cleared, allowing us to advance our REVOLUTION clinical program for VYD2311, a monoclonal antibody aimed at preventing COVID-19.Join us at Invivyd and be a part of making a significant impact in the healthcare landscape.

We are in search of a highly skilled Director of Biostatistics to take on the role of Study Statistician across several drug development programs. This pivotal position will involve crafting statistical strategies from the early stages of development through to regulatory submissions, collaborating cross-functionally to facilitate data-driven decision-making while upholding scientific and regulatory standards.Key ResponsibilitiesDevelop and oversee statistical strategies for various clinical studies throughout all phases of development.Contribute to Clinical Development Plans and represent Biostatistics in cross-functional teams.Design clinical studies, author and review protocols and Statistical Analysis Plans (SAPs), and supervise interim and final analyses.Ensure the quality, accuracy, and reproducibility of statistical outputs in partnership with programming teams and CROs.Assist with regulatory submissions (including INDs, NDAs, BLAs, MAAs), including interactions with health authorities and integrated summaries (ISS/ISE).Oversee external vendors and mentor junior statisticians or contractors.Contribute to scholarly publications, conference presentations, and continuous improvement initiatives.

Zenas is a pioneering biopharmaceutical company at the clinical stage, dedicated to leading the charge in developing and commercializing groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic approach combines a highly experienced leadership team with a rigorous methodology for acquiring and developing product candidates worldwide, ensuring that we deliver exceptional clinical benefits to patients. We are currently advancing two late-stage candidates: obexelimab and orelabrutinib. Obexelimab is our flagship product, a bifunctional monoclonal antibody engineered to bind CD19 and FcγRIIb, prevalent across B cell lineages, to inhibit the activity of cells associated with various autoimmune diseases without causing depletion. We believe that the unique mechanism of action of obexelimab, along with its self-administered subcutaneous injection regimen, positions it to effectively combat the pathogenic role of B cells in chronic autoimmune disorders. On the other hand, orelabrutinib is a potentially best-in-class, highly selective oral Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to penetrate the CNS and address localized inflammation and disease progression in Multiple Sclerosis (MS). Additionally, Zenas is pursuing earlier stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are in search of exceptional talent who share our unwavering commitment to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Our team enjoys a dynamic and fast-paced learning environment, where individual and organizational success is paramount as we strive to establish ourselves as a global leader in immunology and autoimmune disease therapies. We embody our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!Position Summary:The Associate Director of Biostatistics will spearhead the development and execution of statistical methodologies for our global clinical programs. This role involves project leadership and providing technical statistical support. The position reports directly to the Senior Director of Biostatistics.Key Responsibilities:Lead the development and execution of all statistical components for one or more clinical development programs, including contributions to study design, analysis planning, presentation and interpretation of study results, authorship of clinical study reports, regulatory submissions, and publications.Review or author statistical analysis sections of protocols...

The Associate Director of Biostatistics at jobgether leads a team focused on designing and analyzing clinical trials. This position calls for strong experience in biostatistics and a strategic approach to advancing research goals. Role overview This leadership role centers on guiding the biostatistics team through all phases of clinical trial design and analysis. The Associate Director works closely with colleagues from various departments to provide reliable statistical input for clinical study designs and regulatory submissions. What you will do Direct the biostatistics team in planning and analyzing clinical trials Collaborate with cross-functional teams to ensure statistical quality in study design and regulatory documents Develop and oversee statistical analysis plans Support data interpretation to help drive meaningful clinical research outcomes Requirements Extensive experience in biostatistics, especially within clinical research Strong strategic thinking and leadership skills Ability to work effectively with cross-functional teams

Natera, Inc. is seeking an Associate Director of Biostatistics to join its remote team. This leadership role centers on guiding a group dedicated to statistical methods in clinical research. Role overview The Associate Director oversees biostatistics projects that contribute to genetic testing initiatives. The team’s work supports research efforts designed to enhance patient outcomes through data-driven insights. Key responsibilities Lead and mentor a team of biostatisticians working on clinical research studies Develop and apply statistical approaches to support genetic testing projects Collaborate with cross-functional teams to advance research objectives Location This is a remote position based in the United States.

We are seeking an experienced and driven Associate Director of Biostatistics to join our dynamic team at Integrated Resources Inc. In this critical leadership role, you will oversee biostatistical activities, ensuring the highest level of scientific rigor and quality in our clinical research projects. This position is ideal for a strategic thinker with a passion for biostatistics and a commitment to advancing healthcare through innovative solutions.

Join Revolution Medicines, Inc. as a Director of Biostatistics focusing on Late Phase clinical trials. In this pivotal role, you will lead statistical methodologies and provide expert guidance to ensure the integrity and robustness of our clinical data. Collaborate with cross-functional teams to drive the design and analysis of clinical trial data, contributing significantly to our mission of advancing innovative cancer therapies.