Director, Early Phase Biostatistics

Job Summary

Position leads multiple early phase compounds or complex studies contributing to clinical development plan, and responsible for statistical design, analysis and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans with minimal supervision and 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 the projects, in collaboration with 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 operation, CSPV, clinical development and other functions in GPTs.

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, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for 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.
• Act 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 country 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, the efficacy and safety information meets regulatory requirements of the countries and regions the drugs will be submitted. Ensures consistency in derived data definition, statistical analysis and result interpretation; Leads the planning and analysis of integrated efficacy and safety data.
• Mentoring and Coaching Junior Statisticians: Mentoring 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).
• CRO / Vendor Interaction: Participates in reviewing the proposal for CRO selection. Reviews and negotiates timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis methodologies, and interpretation 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 statistics function to Health Authorities meetings as needed.
• Initiatives and harmonization to improve drug development: Lead or contribute to initiatives to optimize the process and save cost in drug development.

Qualifications

PhD in statistics or biostatistics required

7+ years of relevant experience in the pharmaceutical industry required

• 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 package such as NQUERY, EAST, etc.
• Excellent project planning skills.
• Demonstrated expertise in trial design and data analysis.
• Excellent collaborating skills.

Travel Requirements

Ability to travel up to 20%

International travel may be required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$201,840.00 - USD$302,760.00