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AstraZeneca GmbH
Boston, MA, United States
This is what you will do: The Associate Director, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to independently perform and lead statistical work within a project, an indication within a more complex project. This individual is able to lead, and direct biostatistics work either in house or partner
Job Source: AstraZeneca GmbHRBW Consulting
Boston, MA, United States
Position: Associate Director of Biostatistics Location: Hybrid, Boston Type: Full-time The Company: Extensive pipeline of early phase oncology clinical and preclinical compounds developed in-house Mission: Revolutionize disease treatment through cell-based therapies Tight knit group with a culture focused on collaboration and growth Offers a dy
Job Source: RBW ConsultingBicycle Therapeutics
Cambridge
Job Description Job Description Company Description Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffold
Job Source: Bicycle TherapeuticsRBW Consulting
Boston, MA, United States
Welcome to the forefront of medical innovation! Here you will join a clinical-stage biopharmaceutical company that is dedicated to discovering, developing, and commercializing innovative therapies. As Associate Director of Biostatistics you will have the opportunity to utilize unique technology to develop breakthrough treatments with a strong pipel
Job Source: RBW ConsultingPfizer
Cambridge
WHY PATIENTS NEED YOUPfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficac
Job Source: PfizerIntellia Therapeutics
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determ
Job Source: Intellia TherapeuticsDeciphera Pharmaceuticals
Waltham
Company DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.En
Job Source: Deciphera PharmaceuticalsModerna Therapeutics
Cambridge
The Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Moderna’s development programs that are leveragi
Job Source: Moderna TherapeuticsWaltham, MA, United States
Associate Director, Biostatistics
Dragonfly Therapeutics seeks an Associate Director, Biostatistics to lead, develop, and implement statistical analyses to support our early development clinical trials, and provide support to investigators and researchers on experimental design and statistical approaches, requirements, and scientific standards. This role will report to the Head of Biometrics, is hands-on and requires excellent communication skills and frequent collaboration with multiple internal groups. The successful candidate can work independently and thrives in a proactive can-do culture. The work will be fast-paced with evolving needs, requiring adaptability, curiosity, and grace under pressure. This role is an exciting opportunity to be a critical part of the clinical development group, involved in the design, execution, analysis, and reporting of Dragonfly's clinical studies.
Responsibilities:
Serve as the biostatistician in the Clinical Operations and Development team, responsible for all clinical study biostatistics deliverables
Analyze and interpret data from various sources, using standard statistical analysis software to perform appropriate statistical analyses on clinical trial patient data
Develop statistical sections of protocols and statistical analysis plans and assist in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses from regulatory agencies
Make recommendations on appropriate study design, methodology, analytic and operational approach, sample size and power considerations
Ensure that clinical trials meet statistical requirements (ICH, FDA, EMA guidelines) and are conducted with appropriate rigor
Provide ongoing reporting of clinical trial data as needed
Perform exploratory data analyses on patient subgroups
Collaborate with translational science and pharmacokinetic colleagues as needed to analyze early phase trial data
Maintain knowledge of current and emerging trends in state-of-the-art statistical and analytic techniques
Collaborate with, and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to meet project timelines and achieve goals
Collaborate with cross-functional team to review study results and contribute scientific knowledge and analytical skills to the production of documents
Qualifications
Ph.D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 6+ years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 8+ years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations
Ability to analyze, interpret, and summarize clinical and scientific data using a range of advanced statistical techniques for statistical analyses
Skill in preparing graphical data displays
Knowledge of scientific approach and methodologies as well as principles, concepts, methods, and standards of statistical research
Solid understanding of drug development, clinical research, study design, pharmacokinetics, and medical terminology
Experience with CRO vendor oversight is preferred
Experience in oncology and oncology statistical methods used is preferred
Working knowledge of data management principles and regulatory requirements for clinical trials and medical research, including relevant ICH guidelines, US, EU and other regions' regulations
Strong organizational and analytical skills, with the ability to be proactive, think strategically and manage multiple projects simultaneously
Ability to interact effectively with team members, proactively facilitating effective information exchange, with strong communication and problem-solving skills
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
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Email Alert for Associate Director, Biostatistics jobs in Waltham, MA, United States
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