*Onsite San Diego, CA highly preferred )once everyone returns to the office TBD), however will still consider remote candidates. If remote, candidate will need to be open to traveling to San Diego a maximum of once a month for a full work week (client covers all travel costs)
This position will work closely with Biometrics leadership in identifying project demands and resource needs. This role will be responsible for facilitating Biometrics team resources, which includes programming and data management, to provide strategic, scientific and statistical leadership to the assigned clinical development program(s), with guidance from the Vice President, Biometrics. This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory and quality requirements are met and that plans are aligned with development goals. The incumbent will lead the Biometrics team in study design, statistical analysis, reporting, and interpretation of data. This role will provide hands-on support to project teams by conducting statistical analysis, overseeing external vendors, and working closely with programming and data management to plan, organize, coordinate, review, and ensure timeliness and quality of Biometrics deliverables for assigned projects. The incumbent will collaborate with cross-functional teams composed of internal and/or external experts. This role will contribute to the overall efficiency and best practice running of the Biometrics group.
- Represent the statistics function and provide strategic input and statistical leadership in support of multiple clinical studies or projects.
- Responsible for the planning and delivery of the Biometrics components required to support the analysis and reporting needs of clinical development projects. Work directly with the project team and external vendor to identify statistical issues, and to propose and implement solutions.
- Provide statistical and strategic input in support of study reports, regulatory documents, publications, and other internal or external requests. Perform statistical analyses as needed.
- Prepare, review and/or approve SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
- Provide statistical oversight to internal and/or external Biometrics teams to ensure timeliness and quality of deliverables.
- Lead or contribute to the development and maintenance of Biometrics-related SOPs, work practice documents, technical standards, and specification documents.
- Research and apply new statistical approaches as needed. Initiate and drive innovation by implementing relevant innovative designs in the support of program strategy. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.
- Contribute to the professional development of Biometrics team members through mentorship, conducting trainings, or coaching.
- Master’s Degree in Statistics/Biostatistics is required, Ph.D. is preferred.
- 8-10 years (+MS) or 6-8 years (+PhD) of relevant experience in the biopharmaceutical industry. Ability to manage multiple, complex tasks with competing timelines.
- Minimum of 6 years hands-on experience in all tasks of a Lead Statistician, including late stage drug development, submissions, and Health Authority interactions. Experience with disease registries is a plus.
- Vendor and matrix management experience.
- In-depth knowledge of the drug development process, from early to late stage. Experience in orphan or rare diseases is preferred.
- Strong understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions.
- Experience with data pooling to support Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) and periodic reports.
- Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations.
- Proficiency in SAS programming to produce ad hoc tables, listings and figures. Experience with other statistical software such as R preferred.
- Ability to manage multiple, complex tasks with competing timelines.
- Excellent communication and collaboration skills with internal and external team members. Ability to explain statistical concepts to non-statisticians and to educate study team members in the proper use of statistics.
- Solution oriented, attention to detail, interest and ability to perform in a high-demand and fast-moving working environment.
- Highly developed organizational and leadership skills.
- Ability to travel (up to 20%) domestically and internationally.
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