Staff Biostatistician

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

📋 Description

• Lead the statistical evaluation of asset acquisitions and provide the final statistical judgment to guide acquisition decisions.

• Establish portfolio-wide benchmarks for trial design, oversee the design of the most intricate trials, and assess other designs for structural risk.

• Manage high-stakes interim and final analyses, including responsibilities at the board level.

• Act as the principal statistical authority in regulatory discussions.

• Author and advocate for the statistical rationale in briefing materials, submissions, and meetings with agencies.

• Develop statistical standards, templates, and standard operating procedures (SOPs).

• Drive the implementation of statistical standards throughout the team.

• Mentor fellow statisticians as the biostatistics team expands.

• Collaborate closely with Clinical Operations, Data Architecture, Regulatory, and Corporate Development leadership.

• Evaluate the evidence supporting potential acquisitions and influence trial design from initial protocol drafts to regulatory representation.

⛳️ Requirements

• High level of agency, a proactive approach, and a strong commitment to transforming health treatment development.

• PhD or Master's degree in Biostatistics, Statistics, or a related discipline.

• Over 9 years of experience in clinical biostatistics.

• Proven experience in preparing statistical content for FDA submissions, including IND, NDA, or BLA.

• Independently directed statistical strategy across multiple trials.

• Familiarity with complex or adaptive trial designs.

• Proficient in R or SAS.

• Experience supervising the programming efforts of others.

• Conducted interim analyses with significant go/no-go or safety implications.

• Represented statistical viewpoints directly to regulatory bodies.

• Capability to serve as a trusted statistical advisor to Clinical Operations, Regulatory, and Corporate Development leadership.

🏝️ Benefits

• Competitive salary.

• Meaningful stock options.

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

• Health insurance coverage through our PEO Trinet.

• $40 monthly wellness allowance.

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

• $2,000 Learning and Development allowance each year for courses, certifications, and personal development.

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

• Access to gym and retail discounts through Happl.

• Monthly lunch voucher for remote teams.

• Charity events and fundraising opportunities through the Forward Trust.