Senior Biostatistician

Job title: Senior Biostatistician

About the Role 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. Provides strategic inputs to the drug development plan and regulatory documents with minimal supervision. Interacts with global project teams, Health Authorities, CROs, programmers, and statisticians. Applies innovative trial designs and modeling in collaboration with the statistical innovation group, precision medicine biostatistics group, and RWD group. Collaborates with cross-functional project leaders from translational medicine, clinical operations, CSPV, and clinical development within GPTs to optimize statistical handling of programs.

What You'll Do

• Provide input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, with appropriate designs and regulatory information to be collected.
• Lead the implementation of statistical methodologies and address specific statistical issues in design and modeling of responsible clinical studies. Act as statistical expert on assigned projects and guide the team in using efficient or innovative study designs considering regulatory requirements. May serve as lead statistician for certain studies and ensure the study designs are scientifically sound and regulatory compliant. Ensure consistency in data definitions, statistical analyses, and interpretation; lead planning and analysis of integrated efficacy and safety data.
• Mentor and coach junior statisticians on Protocol Development, Statistical Analysis Plan, Statistical Analysis, Results Interpretation, and CSR.
• Participate in CRO / vendor interactions: reviewing CRO proposals, negotiating timelines, and guiding CRO biostatisticians and programmers on data definitions, analysis methodologies, and interpretation; ensure timely delivery of high-quality deliverables.
• Global Health Authority interaction and negotiation: author documents and responses submitted to Health Authorities globally with guidance; represent statistics in Health Authority meetings as needed.
• Initiatives and harmonization: lead or contribute to initiatives to optimize the drug development process and reduce costs.

What We're Looking For

• PhD in statistics or biostatistics.
• 7+ years of relevant experience in the pharmaceutical industry.
• Expert knowledge of drug development and statistical methodologies; excellent programming skills in SAS and/or R.
• Excellent oral and written communication; working knowledge of statistical software such as NQUERY, EAST, etc.; excellent project planning; demonstrated expertise in trial design and data analysis; excellent collaboration skills.
• Willingness to travel up to 20%; international travel may be required.

Nice to Have

• Experience with innovative trial designs and modeling, in collaboration with the statistical innovation group, precision medicine biostatistics group, and real-world data group.

Compensation & Benefits

• Salary range: USD 201,840.00 - USD 302,760.00 per year.
• Benefits: See Benefits Summary PDF.