Associate Director, Biostatistics

Company: ONO PHARMA USA, INC.
Location: Cambridge
Posted on: November 25, 2022

Job Description:

Position Summary: In collaboration with project team members, provides statistical/strategic input to the clinical development plan and develops the clinical development plan, develops protocol and statistical analysis plans for clinical studies, conducts statistical analyses, and provides statistical interpretation of analyses results, while exerting a high degree of expertise in biostatistics. The incumbent also contributes to reporting clinical study result to regulatory authorities, marketing applications and approvals and serves as an integral member of the clinical development team.
Responsibilities and Duties:

• The Associate Director (AD), Biostatistics is responsible and accountable for the statistical science aspects of clinical studies and projects. The AD will be responsible for effective communication within the company and, where appropriate, with external organizations regarding actions related to the successful completion of statistical activities within the studies/projects.
• The AD will lead and manage all statistical activities within clinical studies and projects, including contributing to study design and selection of appropriate data analysis methods, sample size estimation, and working closely with other functional members, external consultants, key opinion leaders, medical advisors and CRO's/contractors, to ensure the quality and integrity of the data is maintained while identifying, and minimizing where possible, risks to the studies/projects.
• Provides appropriate statistical review and interpretation of any pre-clinical data and clinical data from other studies conducted by other parties for the same compound. Identifies relationships and trends in data, as well as any factors that could affect the results of research.
• Contributes to and is accountable for the setting up, implementation, and reporting of clinical studies with regard to statistical aspects of the studies. These responsibilities include, but are not limited to:
• Providing input into the selection of service providers (SPs)/contractors from a statistical aspect in conjunction with the study team.
• Being responsible and accountable for developing and maintaining study documents with regard to statistical aspects of the studies, e.g., including, but not limited to, the Statistical Analysis Plan (SAP).
• Providing input to study documents, e.g., a study plan, study protocol, data management plan, operational documents, clinical study report, and/or authoring relevant sections of study documents.
• Reviewing and approving SPs' study documentation for statistical areas.
• Managing SPs/contractors and overseeing their performance and quality of work to ensure they meet an agreed study plan, contracts and any study specific requirements with regard to statistical aspects of the studies.
• Ensuring data meets the required standards for regulatory submission to applicable agencies (for example, FDA). May include, but not limited to:
• Review of data (using tools such as Pinnacle 21) to ensure compliance with CDISC standards (ADaM and Define XML).
• Review of applicable Reviewers Guides.
• Ensures statistics-related processes are compliant with applicable regulatory requirements.
• Actively seeks feedback and monitors the quality of statistics SPs work on an on-going basis, through review of appropriate documentation.
• Acts as an advisor to clinical/research scientists engaged in the scientific aspects of clinical development studies/projects and provides statistical programming support (via SAS, R, and other packages), as needed.
• Ensures knowledge transfer during and at the completion of the studies/projects.
• Continues to update knowledge and keep abreast of changes within the field of Statistics in Clinical Development. Implements new ideas and advanced processes, where applicable.
• And any other duties, as assigned.
  Disclaimer: This Job Description identifies the essential job functions and skills needed by the persons or persons assigned to this position. These functions and skills are not intended to be a complete and exhaustive list of all of the responsibilities, functions, and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the Company's discretion and should in no way be construed as an employment contract.
  Educational Requirements: This position requires a Ph.D. or a Master's degree in Statistics, Mathematics, Biometrics or Medical Statistics or a related discipline, or equivalent in work experience.
  Experience:
  • At least 6 years of statistics experience with a Ph.D. degree or 8 years with a Master's degree, or the equivalent in work experience within the pharmaceutical industry (including contract research organizations (CROs)), biotechnology or medical sector, including clinical trial design, analysis and reporting. Experience in Phase III pivotal clinical development studies, with submission of marketing applications to regulatory agencies is required.
  • Demonstrated expertise in the application of statistical methods in drug/device development for the treatment of disease, along with knowledge of health authority standards of statistical analytics. Must possess experience in analysis and interpretation of study results, and authoring of study reports that are accurate and reproducible.
  • Possesses knowledge and pharmaceutical experience in the creation of clinical development strategic planning and the design and implementation of clinical studies.
  • Experience with new drug application (NDAs) submission to regulatory agencies, specifically concerning the description and analysis of each controlled clinical study, and the integration of summary information about the safety and efficacy (Integrated Summary of Safety and Integrated Summary of Efficacy) of a drug/device product.
  • Successful track record of managing CROs conducting statistical aspects of clinical trials.
  • Understanding of and compliance with the principles of GCP guidelines and global regulatory requirements.
  • Demonstrated knowledge of and experience with FDA regulations and guidelines, in particular statistical analysis and CDISC standards.Proven experience in all aspects of clinical trial execution with the ability to follow SOPs and accepted practices. Possesses a clear understanding of the work performed by other Clinical Development functions and how they collectively interact and contribute to the drug development process.
    Other Skills and Abilities:
    • Ability to handle multiple tasks, possessing strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines
    • Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment, with competing priorities.
    • Ability to oversee and manage a CRO's statistical analysis of assigned clinical trials.
    • Able to interact effectively at all levels within the organization, as well as with external partners and clients.
    • Proven ability to work independently with minimal supervision, as well as in a multi-cultural team environment.
      Mathematical Ability:
      • Mathematical capabilities required for data analyses.
      • Mathematical capabilities to review and comprehend statistical data.
        Systems/Computer Skills:
        • Requires strong statistical programming skills in SAS.
        • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
          Other:As ONO is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.
          Language Skills:
          • Must have excellent communication and presentation skills (written and verbal).
          • Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of statistics to drug development and study outcomes.Business Travel:This role requires the incumbent to travel, which will be primarily domestic. However, the incumbent may have to occasionally attend meetings at ONO Corporate Headquarters in Japan. Travel will be scheduled based upon the needs of the business, up to 10% of the time.
            To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role.

Keywords: ONO PHARMA USA, INC., Cambridge , Associate Director, Biostatistics, Executive , Cambridge, Massachusetts