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The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed.

YEAR

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. How you will make an impact: + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed What you'll need (Required): + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience What else we look for (Preferred): + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $132,000 - $186,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences

Principal Biostatistician

Analysis Skills

Bayesian Networks

Biostatistics

Biotech and Pharmaceutical

Cardiovascular Disease

Case Report Form (CRF)

Clinical Data

Clinical Data Collection

Clinical Practices/Protocols

Clinical Trial

Compensation and Benefits

Consulting

Data Analysis

Data Modeling

Data Quality

Database Programming

Detail Oriented

Drug Development

External Audit

FDA (Food and Drug Administration)

GCP (Good Clinical Practices)

Healthcare Providers

ISO (International Organization for Standardization)

Internal Audit

Leadership

Medical Affairs

Medical Equipment

Microsoft Access Database

Microsoft Excel

Microsoft Office

Microsoft PowerPoint

Microsoft Word

Presentation/Verbal Skills

Problem Solving Skills

Product Development

Product Support

Publications

Quality Assurance

Quality of Care

Regulations

Regulatory Submissions

Relationship Management

Reporting Skills

Sales Management

Standard Operating Procedures (SOP)

Standards Development

Statistical Modeling

Team Player

Technical Writing

Vaccination

Writing Skills

FEED

As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

<div class="content-intro">Arrowhead Pharmaceuticals, Inc. (Nasdaq:  ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. </div>The Position We are seeking a stellar biostatistician (Senior Associate) to join our rapidly growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others.Responsibilities<ul><li>Support statistical aspects of clinical trials including input on study design, randomization, sample size calculations, and statistical analysis plans (SAPs)</li><li>Draft and contribute to statistical methods sections of protocols, SAPs, and clinical study reports (CSRs)</li><li>Perform data analyses using SAS and/or R, and assist with interpretation of results</li><li>Collaborate closely with data management and statistical programming teams to ensure high-quality data and analysis outputs</li><li>Participate in the development of summary tables, figures, and listings for regulatory submissions and publications</li><li>Assist in reviewing and QC of statistical outputs and documents</li><li>Support the evaluation of statistical methodologies and explore innovative analytical techniques as needed</li><li>Contribute to departmental process improvements, documentation, and knowledge sharing</li></ul>Requirements<ul><li>PhD in Biostatistics or Statistics</li><li>Hands-on experience with statistical software packages (e.g., SAS and/or R)</li><li>Understanding of clinical trial phases and statistical considerations in clinical research</li><li>Strong attention to detail, organizational skills, and ability to manage multiple tasks</li><li>Effective written and verbal communication skills</li><li>Willingness to learn and take direction while growing into greater independence</li></ul>Preferred<ul><li>1+ years of relevant experience in the pharmaceutical, biotechnology, or CRO industry, is preferred.</li><li>Familiarity with regulatory guidance and industry standards (e.g., ICH E9, CDISC standards such as SDTM and ADaM)</li><li>Exposure to working with CROs or cross-functional clinical trial teams</li><li>Knowledge of pulmonary function therapeutic area and drug development in this TA</li></ul><div class="content-pay-transparency"><div class="title" style="font-weight:600;padding-top:8px">California pay range </div><div class="pay-range">$130,000—$145,000 USD</div></div><div class="content-conclusion">Arrowhead provides competitive salaries and an excellent benefit package.   All applicants must have authorization to work in the US for a company.   <a href="https://arrowheadpharma.com/wp-content/uploads/2023/09/Arrowhead-California-Applicant-Privacy-Policy.pdf" rel="nofollow noopener noreferrer" target="_blank">California Applicant Privacy Policy</a></div>

Arrowhead Pharmaceuticals

Biostatistician (Senior Associate)

Biometrics

Candidate Pipeline

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Research

Clinical Support

Communication Skills

Contract Research Organization (CRO)

Cross-Functional

Data Management

Disease

Documentation

Genetic Diseases

ICH Regulations

Industry Standards

Manufacturing

Medical Products

Multitasking

Organizational Skills

Process Improvement

Project/Program Management

R Programming Language

Research & Development (R&D)

Small Molecules

Statistical Analysis System (SAS)

Statistical Programming Languages

Statistical Quality Control

Statistics

Statistics Software

Technical Leadership

GreenHouseAPI

They are currently seeking a highly skilled and experienced Associate Director of Biostatistics to provide leadership to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Please Have: MS/MA degree in related discipline and a minimum of 9 years of related experience; or, PhD in related discipline and a minimum of 5 years of related experience; or, Experience in Oncology and study Phases I-III highly preferred.

Our client is a clinical-stage biopharma company focusing in the Oncology space. They are currently seeking a highly skilled and experienced Associate Director of Biostatistics to provide leadership to develop and execute statistical strategy, design and analyses for clinical trials in all phases. As Associate Director you will apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.This is an onsite role based in the Bay Area.<ul><li>Apply extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases.</li><li>Use initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design.</li><li>Work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.</li><li>Work with project team members on developing clinical protocol.</li><li>Review CRFs, CRF edit checks and CRF completion guidelines.</li><li>Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.</li><li>Review ADaM specifications and verify primary and secondary efficacy endpoints.</li><li>Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.</li><li>Effectively manage CRO to ensure high-quality deliverables within timeline and budget.</li><li>Oversee programming of ADaMs and TLFs for the study.</li><li>Responsible for one or more studies with concurrent tasks and timelines.</li><li>Participate in the validation/QC of key study endpoint analysis and submission deliverables.</li><li>Apply appropriate regulatory guidelines to the projects.</li><li>Guide the successful completion of major programs, projects and/or functions.</li><li>Develop technical and/or business solutions to complex problems.</li><li>Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.</li><li>Performs a variety of complicated tasks with a wide degree of creativity and latitude.</li></ul>Please Have:<ul><li>MS/MA degree in related discipline and a minimum of 9 years of related experience; or,</li><li>PhD in related discipline and a minimum of 5 years of related experience; or,</li><li>Experience in Oncology and study Phases I-III highly preferred.</li><li>Experience in Biotech/Pharmaceutical industry preferred.</li><li>Experience with managing CROs in the conduct of clinical trials.</li><li>Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.</li><li>Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.</li><li>Knowledge of appropriate regulations, industry standards and guidance documents.</li><li>Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.</li><li>Developed/reviewed SDTM/ADaM specifications</li><li>Strong SAS programming knowledge.</li><li>Complete understanding and wide application of technical principles, theories, concepts, and techniques.</li><li>Have good general knowledge of other related disciplines.</li></ul>

Penfield Search Partners

Associate Director Oncology Biostatistics

Budgeting

Business Development

Business Solutions

Clinical Data Management

Medical Writing

Oncology

Quality Control

Regulatory Requirements

HaleyMarketing

PERMANENT

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ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. 

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Insights & Analytics ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.     Our Health Economics Outcomes Research (HEOR) vision is to combine scientific and methodological rigor with strategic thinking. We work with our clients to go beyond delivering high quality studies, to helping them make sure the work they are undertaking are the right ones to support their strategic priorities, and even shape those priorities.As a HEOR associate consultant you will need to support projects that are involved in study design, evidence generation and evidence communication. In HEOR, effective evidence communication is not just about presenting data—it’s about translating complex science into clear, credible, and actionable insights that resonate with diverse stakeholders. Our vision is to elevate the role of evidence as a strategic catalyst for informed decision-making—ensuring that every message we craft bridges clinical value, real-world relevance, and payer priorities. By combining scientific rigor with strategic storytelling, we aim to shape access, influence policy, and ultimately improve outcomes for patients worldwide. What You’ll Do: In the Decision Analytics Associate Consultant - HEOR Evidence Generation in the Insights and Analytics Group will.. <ul><li>Design and develop real-world evidence research studies, including study protocols, statistical analysis plans, and manuscript outlines</li><li>Write, edit, and review scientific publications intended for peer-reviewed journals, including manuscripts.</li><li>Collaborate with global delivery teams (e.g., statisticians, programmers) to execute statistical analyses</li><li>Interpret and communicate scientific and analytical findings in a way that is clear, accurate, and aligned to the client's objectives</li><li>Engage directly with clients, including epidemiologists, biostatisticians, and medical affairs leaders, to align study outputs with strategic goals </li><li>Provide client and ZS teams project status updates. </li><li>Create project deliverables and implement solutions. </li><li>Advance problem-solving skills and improve ZS’s capabilities; </li><li>Guide and mentor Associates on teams. </li></ul>What You’ll Bring <ul><li>Graduate-level degree (Master’s or higher, such as a PhD) with 2–3 years of relevant work experience, and strong academic grounding in biostatistics, epidemiology, public health, health economics, or a related quantitative field</li><li>1–4 years of relevant experience in research, publications, or consulting (can include graduate work); PhD may substitute for post-graduate experience</li><li>Demonstrated experience designing, conducting, and publishing scientific research (e.g., peer-reviewed publications, poster presentations)</li><li>Knowledge of statistical methods and analysis, with ability to design analyses (programming can be supported by others)</li><li>Strong scientific writing skills and experience drafting or reviewing manuscripts for publication</li><li>Exceptional attention to detail and high standards for scientific rigor</li><li>Ability to translate technical findings into clear insights for diverse audiences, including commercial and medical teams</li><li>Strong collaboration skills and a passion for working across functions and disciplines</li><li>Fluency in English</li><li>Client-first mentality</li><li>Intense work ethic</li><li>Collaborative spirit and problem-solving approach</li></ul>

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How you’ll grow:<ul type="disc"><li>Cross-functional skills development & custom learning pathways</li><li>Milestone training programs aligned to career progression opportunities</li><li>Internal mobility paths that empower growth via s-curves, individual contribution and role expansions</li></ul> Perks & Benefits:At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away, and professional development. With robust skills‑building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in <a href="https://www.zs.com/careers/where-we-work/north-america/united-states" target="_blank" rel="noopener">United States</a>, visit <a href="https://www.zs.com/careers/where-we-work/north-america/united-states" target="_blank" rel="noopener">ZS US office locations | Where we work | ZS</a>.                Hybrid working model:We are committed to giving our employees a flexible and connected way of working.  A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel:Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed.  Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying?At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. <a href="https://www.zs.com/about/inclusion-and-belonging" target="_blank" rel="noopener" data-auth="NotApplicable">Learn more</a> about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At: <a href="https://www.zs.com/" target="_blank" rel="noopener" data-auth="NotApplicable">www.zs.com</a>

Biostatistician Jobs in California

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Biostatistician Jobs in California

Principal Biostatistician Edwards Lifesciences

Biostatistician (Senior Associate) Arrowhead Pharmaceuticals

Associate Director Oncology Biostatistics Penfield Search Partners

Decision Analytics Associate Consultant - HEOR Evidence Generation ZS

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