Our client is a clinical-stage biopharma company focusing in the areas of Neurology, Rare Diseases, and Neurodegenerative Disorders.
They are currently seeking a highly skilled and experienced Senior Director of Biostatistics to be responsible for managing and delivering project goals effectively, ensuring compliance and timely execution of statistical strategies for global clinical trials.
In this role you will have 2 direct reports (both Director level) and full responsibility for a very important study now in Phase III and moving into submission.
Extremely competitive compensation package.
Key Responsibilities :
- Define the statistical strategy for assigned projects, applying appropriate methodologies to study designs and data analyses throughout all phases of clinical trials (Phase I-IV).
- Provide expert statistical input and consultancy for global clinical trials and translational medicine research.
- Ensure rigorous statistical and scientific decision-making throughout the project lifecycle.
- Collaborate with internal and external stakeholders on study design, analysis, reporting, and communication of clinical trial results.
- Author and review critical documents including briefing documents, protocols, Statistical Analysis Plans (SAP), and clinical study reports (CSR).
- Support project and clinical study teams with go / no-go criteria, summary reports, and results interpretation.
- Participate in regulatory interactions, including IND / CTA filings and safety reporting.
Requirements :
- Ph.D. in Statistics or a related discipline with 10+ years of experience, or MS with 15+ years of experience in the biotechnology industry.
- Proven interaction and submission experience with FDA and EMA regulatory bodies.
- Expertise in project and people management, particularly in developing Neuroscience or Rare Disease programs is a must.
- In-depth knowledge of life cycle management and a consistent track record of applying statistical principles to achieve regulatory approvals.
- Extensive hands-on experience with Biostatistics deliverables, including study design, protocol development, and statistical analysis plans.
- Up-to-date knowledge of industry and academic developments in Neuroscience, with the ability to apply this knowledge to clinical study design and analysis.
- Demonstrated flexibility and innovative problem-solving capabilities in a dynamic environment.
- Strong leadership, project management, collaboration, communication, and organizational skills.
- Advanced programming skills in SAS, R, and other relevant statistical software.
- Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling techniques.
Director of Biostatistics (USA Remote)
We are currently looking for a highly motivated Director of Biostatistics to join our Neurovascular Medical Science and Clinical Affairs group. This position can be based out of Irvine, California, or remote within the United States. Remote working/work at home options are available for this role. ...
Senior Director, Biostatistics
Senior Director, Biostatistics – Transcatheter Heart Valve. Senior Director of Biostatistics, THV. Directing biostatistics activities with overall responsibility of managing vendors, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through ...
Ormco Senior Director, Marketing (Remote-US)
Director of Marketing will lead the end to end responsibilities for new product introductions from ideation to program development to global commercialization by coordinating with marketing counterparts. ...
Remote Senior Tax Manager/Director - Partnerships
Job Title: Senior Tax Manager/Director. Due to the continouous growth of our firm we are looking to add a Senior Tax Manager / Director to the team with unlimited potential for growth opportunities! Looking for someone who has partnership expertise. Location: REMOTE, work from anywhere!. The average...
Senior Project Manager / Associate Director, Project Management - Metabolic Disease (Obesity/T2 Diabetes/CV) - US or Canada Remote Based
Associate Director, Project Management. Senior Project Manager / Global Project Lead. Location: While this role is remote/hybrid, candidates must reside. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare dise...
Director, Biostatistics (Remote)
The Director, Oncology Early Development Biostatistics is the statistical lead on Oncology Early Development Jazz Pharmaceuticals drug development projects, and will act as a statistical expert across all studies in the project(s). This position can have direct reports up to Associate Director level...
State Credits & Incentives Senior Manager/Director - Remote Eligible
A typical day as a State Credits & Incentives Senior Manager/Director might include the following:. ...
Senior Director Biostatistics
They are seeking a Senior Director of Biostatistics to provide statistical input and support for clinical trial design, conduct data analysis, and results interpretation. The Senior Director, Biostatistics will be responsible for providing statistical input and support for clinical trial design, con...
Senior Director, Biostatistics
Reporting to the Head of Biometrics, the Senior Director of Biostatistics is responsible for biostatistics tasks for all phases of clinical trials including oversight of CRO biostatistics activities and supporting other functional areas such as programming, data management, clinical development and ...
Senior Director, Biostatistics
Are you passionate about using your statistical expertise to drive the development of innovative therapies for life-altering diseases? We are seeking an experienced and passionate Permanent Senior Director of Biostatistics to join our dynamic team in the life sciences industry. Our Client was founde...