Proclinical is currently recruiting for a Director of Biostatics for a leading biotechnology firm located in San Diego, CA.
- 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.
Skills and Requirements:
- 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.
If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.