Director, Biostatistics

US-NJ-Princeton
Category
Biostatistics
Type
Regular Full-Time

Position Summary

This position will have direct responsibility including clinical trial design and execution, analysis and reporting of data, and authoring/review of scientific and regulatory documents. The Director, Biostatistics will have responsibility for CRO oversight, management of statistical projects, and the ability to work cross functionally with other departments.  Individual must have oncology experience.

Responsibilities

 

 

  • Assists with designing the statistical aspects for clinical trials and related activities (e.g.-DMC).
  • Writes (as primary writer or through management of biostatistician vendor) and finalizes statistical sections of clinical protocols and respective statistical analysis plans (SAPs).
  • Is a signatory for finalization of clinical protocols for statistical sections.
  • Analyzes and helps interpret clinical data.
  • Creates/authors statistical sections of scientific and/or regulatory documents, e.g.-IND etc.
  • Represents and defends protocol designs and subsequent analyses during meetings with regulatory agencies and/or IRBs.
  • Supervises and manages external contracted biostatisticians to ensure quality performance and meeting of timelines (e.g.-DMC, PK, IXRS, biostatistical programming, SAP etc.).
  • Keeps management current on project status and provides ongoing risk assessments.
  • Helps to develop continuous improvement for Taiho biostatistical processes.
  • Performs other statistical analyses or duties as required (e.g.-DMC, pK, IXRS, biostatistical programming, SAP etc.).
  • Monitors CRO budgets, RFP, invoices management, scope of work etc.
  • Works cross-functionally with other line functions and Taiho Japan.
  • Monitors the changing regulatory requirements and participates in key industry and regulatory meetings applying knowledge as needed.
  • Manages activities associated with IB updates, DSUR, PSUR and other required reports.
  • Maintains and applies knowledge of computerized systems, CDISC, STDM structure, data management requirements, interpretation of guidance documents published by FDA and EMA.
  • Assists Taiho Japan in harmonizing the data management and biostatistics aspects throughout all Taiho companies.

 

Qualifications

Educational Requirements:

  • PhD in Biostatistics, Statistics, or equivalent education

Experience:

  • 10+ years of industry experience
  • Experience with oncology studies phase 1-2-3-design, all three is a plus.
  • Bayesian study-design an advantage.
  • SAS programming abilities is an advantage.

Other Skills and Abilities:

  • Excellent writing skills.
  • Highly detail and quality oriented.
  • A positive attitude, flexibility and a proactive thought process.
  • Must be able to travel domestically and internationally. Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.

Language Skills:

  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to effectively present information to top management, public groups, and/or boards of directors.

Mathematical Skills:

  • Ability to comprehend and apply principles of advanced statistical theory.

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical form and deal with several abstract and concrete variables.

Computer Skills:

  • Strong computer skills in industry standard statistical programming.

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk.
  • The employee must utilize close vision and be able to adjust focus.
  • Infrequent travel is anticipated.

Work Environment:

  • The noise level in the work environment is usually quiet.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

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