Job description
Director/Senior Director, Biostatistics
Summary
In this new role, reporting to the Vice President, Biometrics you will be working with cross?functional clinical teams responsible for statistical activities across clinical programs, including overseeing statistical deliverables outsourced to clinical CROs.
Your Role:
Summary
In this new role, reporting to the Vice President, Biometrics you will be working with cross?functional clinical teams responsible for statistical activities across clinical programs, including overseeing statistical deliverables outsourced to clinical CROs.
Your Role:
- You will serve as a biostatistics expert for clinical programs
- Provide strategic input to optimize trial designs in late phase registrational studies
- As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables
- Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
- Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
- Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
- Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
- Provide statistical input for clinical documents
- Perform QC/QA of statistical deliverables including validation of key analysis results
- Perform ad hoc statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
- Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
- Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
- Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations
- Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
- Represent in meetings with external parties including regulatory agencies and corporate partners
- Support inspection readiness activities as needed
- Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
- Additional duties and responsibilities as required
- PhD in statistics or related discipline; MS with appropriate years of directly relevant experience
- At least 8 years’ experience in the pharmaceutical or biotech industry
- Experience in the design, analysis, and reporting of clinical trials
- Experience in INDs, NDAs, MAAs, or other regulatory submissions
- In-depth knowledge of statistical methods for clinical trials
- Knowledge of FDA, EMA, and ICH regulations and guidelines
- Proficient in statistical programming (SAS and R)
- Ability to lead statistical efforts for multiple studies
- Fluent in data standards, including SDTM and ADaM
- Experience in outsourced statistical services provided by CROs
- Ability to work independently and act with initiative to address issues
- Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner