Lead Biostatistician embedded in a global biotech team focused on autoimmune disease, designing and implementing statistical methodologies for complex clinical trials and research projects.
Compensation
The salary range estimated for this position based in Massachusetts is $135,000.00–$175,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Design and implement statistical methodologies for complex clinical trials and research projects
Collaborate with cross-functional teams
Provide strategic guidance on study design and analysis
Contribute to innovative research and advance possibilities for people living with autoimmune disease
Requirements
Advanced Degree in Biostatistics, Statistics, or a closely related quantitative field
Bachelor's Degree in Biostatistics, Statistics, or a closely related quantitative field
Lead a multidisciplinary team to generate high-quality clinical intelligence and evidence across the Breast & Gynaecology portfolio using real-world evidence and AI.
Compensation
The annual base pay for this position ranges from $ 203.213,60 - 304.820,40 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program.
Responsibilities
Define and evolve the Clinical Intelligence & Evidence strategy for Breast & Gynaecology
Provide scientific leadership in epidemiology and Real-World Evidence
Work closely with drug development teams to translate clinical and portfolio questions into research objectives
Apply Real-World Evidence to support clinical development questions
Shape the appropriate use of machine learning and AI within Real-World Evidence
Requirements
Advanced degree (PhD, MPH, MD, or MSc) in Statistics, Epidemiology, Public Health, Data Science, Mathematics, or related field
Nice to have: Oncology breast and/or gynaecological cancers
The annual base pay for this position ranges from $ 203.213,60 - 304.820,40 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program.
Responsibilities
Define and evolve the Clinical Intelligence & Evidence strategy for Breast & Gynaecology
Provide scientific leadership in epidemiology and Real-World Evidence
Work closely with drug development teams to translate clinical questions into research objectives
Apply Real-World Evidence to support clinical development questions
Shape the appropriate use of machine learning and AI within Real-World Evidence
Requirements
Advanced degree (PhD, MPH, MD, or MSc) in Statistics, Epidemiology, Public Health, Data Science, Mathematics, or related field
Nice to have: Experience within Oncology, particularly Breast and/or Gynaecological cancers
Nice to have: Hands-on experience in data science, machine learning and predictive modelling
Nice to have: Familiarity with advanced approaches such as Bayesian inference, temporal modelling, multimodal modelling, foundation models, and model interpretability and evaluation
Nice to have: Experience with clinical text, electronic health records, imaging or molecular data, including genomics in clinical care or translational medicine
Own the vision, strategy, governance, adoption, and continued development of the Clinical Data Layer, helping clinical data move securely and efficiently from source systems into trusted data products.
Locations (4)
Brussels, Brussels Capital, Belgium
Monheim, North Rhine-Westphalia, Germany
Slough, Berkshire, United Kingdom
Raleigh, North Carolina, United States
Responsibilities
Define and communicate the long-term vision, roadmap, investment case, and business strategy for the Clinical Data Layer.
Establish governance for data products, metadata, reference data, quality controls, access, stewardship, and measures of platform value.
Own the vision, strategy, governance, adoption, and continued development of the Clinical Data Layer. Act as Functional System Owner to help clinical data move securely and efficiently from source systems into trusted data products.
Locations (4)
Brussels, Brussels, Belgium
Monheim, North Rhine-Westphalia, Germany
Slough, Berkshire, United Kingdom
Raleigh, North Carolina, United States
Responsibilities
Define and communicate the long-term vision, roadmap, investment case, and business strategy for the Clinical Data Layer.
Establish governance for data products, metadata, reference data, quality controls, access, stewardship, and measures of platform value.
As Associate Clinical Data Facilitator, you will ensure clinical trial data is accurate, compliant, and ready for submission. You will prepare forms for regulatory authorities and use tools like Python, VBA, and Power BI to automate processes.
Responsibilities
Own the quality and submission-readiness of clinical data forms for assigned trials.
Compile, bookmark, merge and hyperlink sample and completed (e)CRFs and appendices for Clinical Trial Reports and Non-interventional Study Reports.
Prepare (e)CRFs and CDISC submission documents (aCRF, cSDRG) to meet eCTD compliance standards.
Run electronic quality control checks and support submission deliverables at project level.
Support the decommissioning of EDC and eCOA systems, including retrieval and archival of audit trails and access reports.
Lead the vision, strategy, governance, and development of the Clinical Data Layer, ensuring secure and efficient data flow from source systems to trusted data products across the clinical development lifecycle.
Compensation
This position's reasonably anticipated salary range is $148,000-$195,000 annually. The actual salary offered will consider internal equity and may also vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience, among other factors.
Responsibilities
Own the vision, strategy, governance, adoption, and continued development of the Clinical Data Layer
Define and communicate long-term vision, roadmap, investment case, and business strategy
Establish governance for data products, metadata, reference data, quality controls, access, stewardship, and measures of platform value
Partner with architecture and technology teams to enable scalable integration, common data models, interoperability, and reusable clinical data flows
Shape safe, high-value uses of artificial intelligence, intelligent automation, semantic models, knowledge graphs, and agent-based capabilities
Requirements
Bachelor’s degree in data science, computer science, clinical informatics, life sciences, technology, statistics, or a related field
Nice to have: led large-scale business transformation involving clinical data, digital capabilities, and global, cross-functional stakeholders in regulated environments
Nice to have: understanding of clinical data standards, metadata management, data architecture, statistical analysis workflows, governance, and the clinical development lifecycle
Nice to have: familiarity with cloud data platforms, data lakes, data products, application programming interfaces, and modern integration patterns
Nice to have: ability to connect business and technical perspectives and understand artificial intelligence, machine learning, agents, semantic layers, and modern data ecosystems
Senior Director, AI for Clinical Intelligence & Evidence Breast & GynaecologyNewAstraZeneca · Gaithersburg, US
Clinical Data Layer LeadUCB · Monheim, Germany+3 more
Associate Clinical Data FacilitatorNovo Nordisk A/S · Bangalore, India