Job Title
Director, Early Phase Biostatistics (m/f/d)
The Position
This position leads multiple early-phase compounds or complex studies contributing to the clinical development plan, and is responsible for statistical design, analysis, and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans, regulatory responses, and other documents with minimal supervision. This position interacts with global project teams and global health authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. This position utilizes innovative trial designs and modeling to optimize the statistical handling in projects, in collaboration with the Statistical Innovation Group, Precision Medicine Biostat Group, and Real‑World Data (RWD) Group. This position collaborates with cross‑functional project leaders from translational medicine, clinical operations, clinical development, and other functions in GPTs.
Roles and Responsibilities
Drug Development Strategy:
* Provides input to the clinical development plan to ensure the overall strategy can deliver the pre‑specified product profile, is logical, scientifically sound, and that proposed studies have appropriate designs, and that efficacy and safety information to be collected meets regulatory agencies' requirements for the countries and regions the drug is to be submitted
* Leads the implementation of statistical methodologies and addresses specific statistical issues in the design and modeling of responsible clinical studies
Supervision of Statisticians:
* Supervises the study‑level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR)
* Acts as statistical expert in the assigned projects
* Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the countries and regions the compound will be submitted, and helps to maximize the success of the drug product
* May also serve as a lead statistician for certain studies and ensures the study designs are scientifically sound, and that efficacy and safety information meets regulatory requirements of the countries and regions the drugs will be submitted
* Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis, and result interpretation
* Leads the planning and analysis of integrated efficacy and safety data
CRO / Vendor Oversight:
* Participates in drafting requests for proposal for CRO selection
* Reviews and negotiates baseline budget and timelinesGuides CRO biostatisticians and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis file structure, analysis methodologies, and accuracy of analysis results
* Ensures timely delivery of high‑quality deliverables
Global Health Authority Interaction / Negotiation:
* Authors documents and responses submitted to health authorities globally with some guidance from supervisor
* Represents the statistics function in health authority meetings as needed
Initiatives and Harmonization to Improve Drug Development:
* Leads or contributes to initiatives to optimize the process and save costs in drug development
Personal Skills and Professional Experience
Education:
* PhD in Statistics or Biostatistics required
Work Experience:
* 7+ years of relevant experience in the pharmaceutical industry required
Competencies:
* Expert knowledge of drug development and statistical methodologies
* Excellent programming skills in SAS and/or R
* Excellent oral and written communication skills
* Working knowledge of statistical software packages such as NQUERY, EAST, etc.
* Excellent project planning skills
* Demonstrated expertise in trial design and data analysis
* Excellent collaboration skills
Travel Requirements:
* Ability to travel up to 20%
* International travel may be required
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