Our client is a clinical-stage biopharma company focusing in the Oncology space. They are currently seeking a highly skilled and experienced Associate Director of Biostatistics to provide leadership to develop and execute statistical strategy, design and analyses for clinical trials in all phases. As Associate Director you will apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
This is an onsite role based in the Bay Area.
- Apply extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases.
- Use initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design.
- Work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
- Work with project team members on developing clinical protocol.
- Review CRFs, CRF edit checks and CRF completion guidelines.
- Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.
- Review ADaM specifications and verify primary and secondary efficacy endpoints.
- Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
- Oversee programming of ADaMs and TLFs for the study.
- Responsible for one or more studies with concurrent tasks and timelines.
- Participate in the validation/QC of key study endpoint analysis and submission deliverables.
- Apply appropriate regulatory guidelines to the projects.
- Guide the successful completion of major programs, projects and/or functions.
- Develop technical and/or business solutions to complex problems.
- Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
- Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Please Have:
- MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
- PhD in related discipline and a minimum of 5 years of related experience; or,
- Experience in Oncology and study Phases I-III highly preferred.
- Experience in Biotech/Pharmaceutical industry preferred.
- Experience with managing CROs in the conduct of clinical trials.
- Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
- Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
- Knowledge of appropriate regulations, industry standards and guidance documents.
- Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
- Developed/reviewed SDTM/ADaM specifications
- Strong SAS programming knowledge.
- Complete understanding and wide application of technical principles, theories, concepts, and techniques.
- Have good general knowledge of other related disciplines.
