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Director, Biostatistics

Company: Proclinical Group
Location: Texarkana
Posted on: March 17, 2023

Job Description:

Proclinical is seeking a remote Director, Biostatistics for a leading biotech company.Must be eligible to work or be a citizen in the US.Job Responsibility:

  • Leads collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
  • Leads/conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
  • Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
  • Authors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
  • Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
  • Designs and specifies randomization schedules; reviews and approves test randomization lists
  • Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
  • Reviews analysis dataset specifications
  • Performs QC/QA of statistical deliverables including validation of key analysis results
  • Performs ad hoc and exploratory statistical analyses as needed
  • Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results
  • Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
  • Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
  • Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations
  • Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts
  • Represents company regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
  • Serves as a mentor to junior team membersSkills and Requirements:
    • Ph.D. (Strongly preferred) or Master's degree in statistics or related discipline
    • Eight years (Ph.D.) or ten years (Master) or more experience in the pharmaceutical or biotech industry
    • Demonstrated ability and experience in the design, analysis and reporting of clinical trials
    • Experience in NDAs, MAAs or other regulatory submissions desirable
    • In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
    • In-depth knowledge of FDA, EMA and ICH regulations and guidelines
    • Proficient in statistical programming in SAS and R
    • Proficient in statistical design software such as EAST
    • Ability to concurrently lead statistical efforts for multiple studies
    • Understanding of data standards, including SDTM and ADaM
    • Ability to oversee statistical services provided by CRO's and/or contractors
    • Ability to work independently, guide team and junior biostatisticians, and act with initiative to address issues
    • Ability to collaborate effectively with colleagues from all other functions
    • Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) 305-929-0913 or 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.#LI-PB2

Keywords: Proclinical Group, Shreveport , Director, Biostatistics, Executive , Texarkana, Louisiana

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