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Associate Director, Biostatistics

Arena Pharmaceuticals, Inc. • San Diego, CA
a month ago

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.

The Opportunity:

We are seeking an Associate Director of Biostatistics who will be responsible for leading, providing technical leadership, and providing biostatistical support to the Clinical Development research program through design and conduct of clinical studies. This individual will also be responsible for the review and accuracy of clinical data, the evaluation, interpretation, and reporting of study results, and for regulatory submissions to the FDA and other regulatory agencies.

What you will 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
  • For assigned clinical development projects, 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 of all aspects of preparation and execution of SAP to ensure efficiency, accurate, timely and quality outputs
  • Reviews case report forms (CRF) to ensure that protocol objectives are met and project standards are maintained
  • Develops statistical programs or oversees their preparation as needed to perform pre-specified or ad-hoc analyses and prepare data displays; experience with simulation
  • Supplies statistical input for regulatory submissions and in response to FDA/EMA questions
  • Assists with statistical and operational aspects pertaining to Data Monitoring Committees
  • Performs and reports study results of appropriate statistical analyses, in collaboration with other relevant scientific disciplines where applicable, to provide appropriate 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
  • Maintain currency with respect to FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development
  • Become familiar with the disease states and competitors to enhance the level of customer focus and collaboration
  • Provides leadership to the organization, in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design
  • Assists company in the evaluation of Contract Research Organizations (CRO), specifically the biostatistics, statistical programming, and data management functional area
  • Oversees statistical and programming deliverables by CRO (e.g., SAP, CDISC data, Define.xml)
  • Assists the organization in identifying consultants or other external talent, where needed
  • Assist in the development of SOPs and work procedures for biostatistics, statistical programming, and data management
  • Mentor junior statisticians and statistical programmers
  • Other duties as assigned or required

What we expect:

  • M.S. in Statistics, Biostatistics, or Mathematics; PhD preferred
  • 10+ years (M.S.) or 7+ years (Ph.D.) of progressive and relevant experience in pharmaceutical or biotechnology clinical trials
  • Significant experience in full-cycle drug development/pharma required; Experience participating in the commercialization of therapeutics is highly desirable
  • Significant and demonstrated 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
  • Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories and concepts to clinical drug development
  • Effective in communication and team collaboration
  • Demonstrated ability to develop, communicate, negotiate and implement solutions to statistical issues and processes to yield more accuracy and greater productivity
  • Project management and planning skills required; Knowledge of cross-functional department functions/roles
  • Demonstrated ability to handle high volumes of work in a fluid, dynamic, stressful and fast-paced environment
  • Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines
  • Demonstrates excellent communication (verbal/written/presentation) skills
  • Demonstrates sound judgment, facilitation and interpersonal skills
  • Detail-oriented with effective problem-solving and troubleshooting skills
  • Significant experience and understanding of medical terminology
  • Significant experience using Microsoft Office Suite including Project, Excel, PowerPoint required; Experience with SharePoint or similar work management software/systems highly preferred
  • Passion for science
  • Potential for travel (US and International)

What We Offer:

  • To be part of a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute to creative solutions
  • Competitive compensation package including long-term incentives
  • Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
  • Generous matching 401k retirement plan
  • Flexible time off policy and holidays including two company-wide shut-down periods each year
  • Multi-cultural work environment
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and 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.

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