Director, Biostatistics - REMOTE

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Posted 13 days ago United States Salary undisclosed
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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 members

Skills 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) or .

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.