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Remote Director Biostatistics Indication Lead
Boston, MA

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$1 - $2 / yr


Director of Biostatistics

Experienced biostatistician who will be responsible for leading, developing and implementing statistical solutions to optimally support all phases of clinical trials and decision making. The successful candidate will function as a lead statistician across assigned clinical development programs across our portfolio. They may also supervise study level statisticians in-house and at CROs and be accountable for all biostatistics study deliverables. The role will include key trial statistician responsibilities including statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration. Industry experience is required; experience with regulatory filings also strongly preferred.

 

Specific Responsibilities:

 

  1. Area of responsibility
  • Participate in hiring and retaining talent; provide career growth opportunities for staff; Support department head to define resource needs and determine use of in-house contractors or CRO.
  • Provides input into product development strategy by suggesting innovative designs and decision making tools.
  • Selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; Reviews protocols.
  • Oversees execution of statistical analyses, reviews statistical outputs and guarantees results interpretation.
  • Reviews and approves the statistical methods and results sections for clinical study reports (CSR).
  • Reviews regulatory documents such as CSRs, as well as integrated reports and summary documents.
  • Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
  • Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions.  
  • Oversees statistical support to multiple project teams.
  • Works independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.

 

  1. Area of responsibility
  • Responsible for interacting with FDA personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations through direct product responsibility or subordinates.
  • Review regulatory documents such as protocols, IBs, CSRs, and submission packages as well as integrated reports and summary documents.
  • Represent Company for statistical issues in communications with regulatory authorities. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Review data package relevant for submission or making key decisions.
  • Contribute to the interpretation of analysis results interpretation to team members such as medical writer, Physician through direct product responsibility or subordinates.
  • Contribute to the publication plan. Review/approve abstracts, posters, and manuscripts to support Physicians and Medical Affairs through direct product responsibility or subordinates.

 

  1. Area of responsibility

 

  • Leads or contributes to departmental process improvement initiatives and development/revision of SOPs.
  • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP.
  • Contributes to the establishment and maintenance of common formats and templates for key Biostatistics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings).
  • Plan and track project activities, timelines, across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.

 

  1. Other duties as required or directed by the Manager or Functional Management

 

Skills and Education:

 

  • S. in Biostatistics or closely related field
  • D. in Biostatistics or closely related field is strongly preferred.
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
  • Ability to determine appropriate designs and analyses for clinical trials.
  • Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
  • Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
  • Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA).
  • Direct regulatory filing experience
  • Ability to respond to regulator’s inquiries for products undergoing registration and approved products.
  • Proficiency in SAS is strongly preferred.
  • Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
  • Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
  • Generally has 10+ years of relevant pharmaceutical experience, including experience in Oncology and interactions with regulatory bodies

 

Other Relevant Information:

 

  • Some domestic and international travel required


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