Overview of Role:
Serves as the project level biostatistician and provides leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.
Role and Responsibilities:
- Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology
- Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies
- Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses
- Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications
- Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
- Review vendor data transfer specifications and ADaM programming specifications
- Lead assessment and introduction of novel statistical methodologies to implement solutions
- Represent biostatistics function or biometrics department in cross function teams
- Work with department leader to develop and implement department policies, standards and procedures
- Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
- Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
- Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
- Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development
Experience, Education and Specialized Knowledge and Skills:
- PhD 8+ or MS (11+ years of experience) in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience
- Experience in supporting oncology phase II/III clinical studies
- Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
- In-depth knowledge of CDISC standards
- Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.
- Excellent written and verbal communication skills
- Good working knowledge of ICH, FDA and GCP regulations and guidelines
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