Director, Biostatistics Jobs

The Director of Biostatistics is accountable to provide hands on work and lead the biostatistics team to provide strategic, scientific, and statistical leadership to the assigned clinical development...

The Director or Biostatistics will be an integral part of the clinical development team at all steps of development, from study design to approval, and will be encouraged to think outside the box to a...

Provides statistical support as Biostatistics project lead for one or more compounds, including input into design and analysis of clinical trials, vendor oversight, and submission activities. Contribu...

Directs overall statistical activities for the projects assigned including implementing efficient, consistent, and practical processes for Biostatistics and develops, implements and monitors resource...

Understand drug development issues common to other functions (eg clinical operations, regulatory affairs) and work to achieve solutions that balance the needs of both biostatistics and the other group...

Shapes Biostatistics function, creates and leverages programs, policies, and procedures to provide value added solutions for Biostatistics.

Provide leadership and long-term vision to the Biostatistics group to support the Company to meet its regulatory, scientific and business objectives...

Represents biostatistics project lead, with accountability of biostatistics deliverables, including biostatistics support of clinical development planning, clinical study designs, protocol writing, an...

Solid knowledge and experience in vaccine development process, including evaluation of epidemiologic data for definition of key endpoints and assessment of correlates of risk...

Provide leadership and represent biostatistics at high-level cross-functional interactions related to scientific goals, filing execution and/or strategy...

The Associate Director of Biostatistics is the key client interface for all statistical issues and discussions. Leads the cross functional internal team members to ensure that project work is complet...

Participates in approved process improvement initiatives; mentors new/junior biostatisticians; keeps up to date current on statistical methodology and computing development. Conducts modelling and sim...

Propose and critically evaluate asset development plan for either BD opportunity or internal development project via scenario analyses, statistical trial simulation and meta-analyses of appropriate hi...

Provide leadership and expertise in analytical support of real-world data research, outcomes research, biomarkers, digital solutions and artificial intelligence/machine learning (AI/ML) projects...

Perform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members as required.

You are an expert communicator and are adept at explaining complex topics to stakeholders with a variety of non-technical backgrounds.

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Provide input and implement standard operating procedures for the statistical function including best statistical practices and QC standards. Work closely with the statistical programming team and pro...

Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews stu...

This position will be responsible for providing guidance on clinical development plans, protocols and analysis, review clinical study reports and regulatory submission materials, and ensure that stan...

Experience in interacting with regulatory agencies is a requirement. Deep knowledge and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy or pediatric products...

Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)...

Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support.

Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses.

Collaborates on design, analysis, validation, and life-cycle support for pharmacokinetic, clinical, and nonclinical biomarker and immunogenicity assays...