Director, Biostatistics

Company: Arena Pharmaceuticals
Location: San Diego
Posted on: January 15, 2021

Job Description:

This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.-- The Director of Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies. What you'll dive into

• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations
• Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements
• Authors or leads the development and execution of SAP
• Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays
• Performs and reports study results of statistical analyses to provide interpretation of data and sound study conclusions
• Collaborates with the programming and data management, functions to ensure data collection and reporting is done in conformance with ongoing practice and regulatory expectations
• Provides leadership to the organization, in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design What we expect
  • MS. in Statistics, Biostatistics, or Mathematics; PhD preferred
  • 10+ years of progressive and relevant experience in full-cycle drug development/pharma required; Experience in the commercialization of therapeutics is highly desirable
  • Significant experience selecting/managing biostatistics CROs and vendors
  • Technical knowledge of database structure, relevant statistical software such as SAS -- , East -- , and R
  • Strong SAS -- and R programming background including macro development and program validation
  • Demonstrated experience leading change implementations using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC, including development of SDTM and ADaM specifications
  • Significant experience using MS Office including Project, Excel, PowerPoint required; Experience with SharePoint highly preferred
  • Potential for travel (US and International) --What you'll get To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives Opportunities to learn and contribute creative solutions Matching 401k retirement plan Paid time off and holidays including a Summer & Winter break Company celebrations Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com . By submitting a resume for consideration, applicants verify that they have read Arena's Applicant Personal Information Privacy Notice . Do you now, or will you in the future, need sponsorship from an employer in order to obtain, renew or extend your work authorization in the U.S.? --*
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