Associate Director, Biostatistics

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

📋 Description

• Act as the principal biostatistician for studies, offering statistical insights into study design, sample size determination, protocol development, statistical analysis plans, randomization strategies, clinical study reports, and interpretation of statistical results.

• Supervise and review statistical documentation for various clinical trials, including TLF shells, electronic case report forms (eCRFs), variable derivation specifications, and outputs from external vendors or internal programming teams.

• Manage biostatistics and statistical programming vendors to guarantee the quality, timeliness, and statistical integrity of deliverables.

• Represent the Biostatistics team on cross-functional study groups, collaborating with Statistical Programming, Data Management, Clinical Development, Clinical Operations, and Regulatory Affairs.

• Ensure that all study-level statistical activities adhere to applicable regulatory requirements and Immunovant standards.

• Plan, deliver, and communicate statistical analyses, data presentations, and scientific reports effectively.

• Employ innovative statistical methodologies to enhance clinical development and support effective decision-making.

• Report directly to the Senior Director of Biostatistics.

⛳️ Requirements

• PhD or MS in Statistics, Biostatistics, Mathematics, or a related discipline.

• 5+ years of experience in the biotechnology, pharmaceutical, or health sectors; 7+ years required for candidates with an MS.

• Familiarity with relevant FDA, EU, and ICH guidelines and regulations.

• Understanding of the drug development process.

• Proven ability to collaborate with a diverse range of stakeholders.

• Excellent written and verbal communication skills, with a keen attention to detail.

• A natural team player who thrives in a cross-functional, fast-paced, and innovative environment.

🏝️ Benefits

• Equity and other forms of compensation may be included as part of a comprehensive compensation package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 401k plan.

• Unlimited paid time off.

• Parental leave.

• Remote work environment.