Senior Director of Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish the statistical strategy as the portfolio expands.

• Oversee the biostatistics, statistical programming, and medical writing departments, including setting priorities, workflows, hiring procedures, and standard operating procedures.

• Personally manage statistics for active and incoming programs from protocol development through to database lock and clinical study report.

• Author and review Statistical Analysis Plans (SAPs), sample size and power calculations, as well as randomization schemes.

• Evaluate outputs at critical milestones, such as interim analyses and Data Safety Monitoring Board (DSMB) packages.

• Act as the primary statistical representative with regulatory bodies through meetings, briefing documents, and responses to queries from health authorities.

• Author and review the statistical sections of regulatory submissions, including Investigational New Drug (IND) and New Drug Application (NDA) filings.

• Assess the statistical rigor of clinical data packages for assets under consideration for in-licensing.

• Evaluate the quality of trial design, endpoint selection, and signal strength.

• Identify statistical risks that may impact development strategy or deal terms.

• Supervise statistical programming deliverables, such as analysis datasets, tables, listings, and figures, ensuring compliance with CDISC standards.

• Oversee medical writing outputs for Clinical Study Reports (CSRs) and submissions.

• Assess external Contract Research Organization (CRO) and Functional Service Provider (FSP) partnerships as necessary.

• Identify opportunities for utilizing AI and machine learning tools to enhance statistical workflows.

• Collaborate closely with colleagues in clinical, medical, data architecture, clinical operations, regulatory affairs, and business development.

• Expand the biostatistics, statistical programming, and medical writing capabilities as the portfolio grows.

• Establish team processes and standards.

⛳️ Requirements

• PhD in statistics or biostatistics with over 10 years of relevant experience in pharma/biotech, or a Master's with over 15 years, including lead statistician experience across multiple early-phase programs, with at least one program completed through CSR.

• Direct interaction with health authorities on various programs, ideally for early-phase INDs (NDAs are also acceptable), including formal meetings and written correspondence; experience with FDA preferred, EMA also considered.

• Required experience in adaptive trial design.

• Proven experience in setting statistical strategy at either a program or portfolio level.

• Strong understanding of CDISC standards, regulatory submission requirements, and contemporary drug development trends.

• Exceptional programming skills, including the ability to independently generate analysis outputs.

• Proficiency in R and/or SAS is preferred.

• Familiarity with the application of AI/ML tools to statistical workflows is a plus.

• Experience in evaluating external clinical data through due diligence, licensing, or M&A activities is highly preferred.

• A proven track record in hiring, managing, and developing statisticians, ideally including building or scaling a biostatistics function.

• Comfortable functioning as both a leader and a hands-on contributor.

• Excellent written and verbal communication skills suitable for executive, technical, and non-technical audiences.

🏝️ Benefits

• Competitive salary.

• Meaningful stock options.

• 27 days of annual leave in addition to 11 National Holidays.

• Health insurance coverage through our PEO Trinet.

• A monthly wellness allowance of $40, which can be spent on a Wellhub membership or wellness activities and expenses of your choice!

• Enhanced Parental Leave: 16 weeks of full pay for the primary caregiver and 6 weeks of full pay for the secondary caregiver.

• An annual Learning and Development allowance of $2,000 to be allocated towards courses, certifications, and professional development.

• Regular company-wide and team events, both in-person and virtual.

• Access to gym and retail discounts via our benefits platform, Happl.

• Monthly lunch vouchers for our remote teams.

• Opportunities for charity events and fundraising through our partnership with the Forward Trust.