Associate Director, Biostatistics

POSITION SUMMARY

The Associate Director, Biostatistics will have a demonstrated ability to oversee and support the biostatistics activities across a single clinical program or group of related studies. This role will provide biostatistics leadership and expertise to project and study teams (including CROs/vendors) and have solid knowledge of the end-to-end clinical research and biostatistics/programming reporting processes.

Additionally, this position provides biostatistics support and leadership for Geron Oncology clinical programs including Phase 1-3 studies. To provide management and oversight of biostatistics CROs and contractors, as well as biostatistics support to preclinical studies and CMC studies as needed.

This position will report to the Senior Director, Biostatistics and will need to have a periodic onsite presence in the East Coast Headquarters of Parsippany, NJ.

REQUIREMENTS/QUALIFICATIONS

Key Competencies:

  • Provides leadership for biostatistics function which supports all aspects of the oncology programs that will be required to enable optimal study design, analysis and reporting
  • Strong technical, scientific and strategic drug development expertise as part of the Oncology Technical Review Committee, the main governance committee for oncology programs
  • Develops processes and standards that are in accordance with GCP and ICH guidelines to enable efficient and consistent biostatistics activities
  • Supervises CRO outputs and biostatistics contractors
  • Acts as primary liaison for statistical issues and programming specifications between medical and clinical operations personnel, CROs, and Biometrics
  • Contributes to protocol development by choosing an appropriate study design and statistical methodology, defining endpoints, calculating necessary sample size, and writing statistical sections of the protocol
  • Develops or reviews statistical analysis plans
  • Leads the clinical study report (CSR) development process, including mapping out timelines, performing statistical analyses, preparing sections of the report, and reviewing the report
  • Establishes and negotiates accurate timelines with internal and external team members for completion of study-related biostatistical activities
  • Represents biostatistics on project teams
  • A flexible and thoughtful mindset about new statistical approaches and be able to communicate effectively with medical, clinical, and programming personnel
  • Generates or reviews and approve tables, listings, and graphs (TLGs) in collaboration with statistical programmers to ensure accurate and appropriate analyses and results
  • Conducts and participates in validation and quality control of project deliverables as necessary
  • Collaborates with internal and external resources (CRO's) to ensure consistency of methods, interpretation, and approach
  • Performs statistical analyses and prepare corresponding sections of the research report, with responsibility for review of entire research report

EXPERIENCE AND COMPETENCIES

The successful candidate will be able to demonstrate the following:

  • PhD in Statistics/Biostatistics with at least 5 years of experience in biotech/pharma industry as a biostatistician, preferably 7 or more years of progressive experience in clinical trials in a biostatistician role
  • Oncology drug development experience is required
  • Later stage clinical trials, NDA/BLA submissions, and experiences with FDA and ex-US regulatory authorities are highly desired
  • Mastery of statistical theory, including standard experimental design and analysis methods
  • Prior experience managing and interacting with CROs
  • Strong implementation skills; must be comfortable with SAS and/or R programming
  • Familiar with ICH and other regulatory requirements related to biostatistical activities
  • Proven leadership capabilities, including an ability to appropriately prioritize and resource to drive for results, to deploy sound judgment in complex situations, to maintain a positive attitude in face of adversity, and to effectively influence and work with others at multiple levels within the organization
  • Excellent written and oral communication as well as strong interpersonal communication skills
  • Proven track record of commitment to the success of others and total ownership and accountability of personal and functional performance