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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 . 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.? --*
      U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Arena Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Arena Pharmaceuticals, San Diego , Director, Biostatistics, Executive , San Diego, California

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