Associate Director, Biostatistics

Immunovant; Durham (NC); A distancia; USD 180.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity and other compensation

Medical, dental, vision

401k

Unlimited paid time off

Parental leave

Descripción de la vacante

Immunovant, Inc. in Durham, NC is seeking a lead biostatistician to collaborate across study teams and vendors to execute the biostatistics strategy. This remote-based role offers exposure to regulatory interactions and rapid biotech growth. Domestic and international travel are required.

You will design analyses, review statistical documents, ensure compliance, and drive innovative methods to accelerate clinical development.

Formación

• PhD or MS in Statistics, Biostatistics, Mathematics, or related field.
• 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area.
• Knowledge of relevant FDA, EU, ICH guidelines and regulations.
• Understanding of drug development.
• Demonstrated ability to collaborate with diverse sets of stakeholders.

Responsabilidades

• Serve as lead study biostatistician, providing statistical input into study design, sample size, protocol, SAPs, and interpretation of results.
• Provide oversight and review of statistical documents for multiple trials, including TLF shells, eCRFs, and vendor deliverables.
• Oversee biostatistics and statistical programming vendors for quality and timeliness.
• Represent Biostatistics on cross-functional study teams and collaborate with partner lines.
• Ensure all study activities comply with regulatory requirements and Immunovant standards.
• Plan, deliver and communicate statistical analyses, data presentations and scientific reports.
• Apply innovative statistical methods to streamline development decisions.

Conocimientos

Statistical analysis

Cross-functional collaboration

Leadership in biostatistics

Regulatory knowledge

Educación

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Herramientas

SAS

R

eCRF systems

Clinical trial systems

Descripción del empleo

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.

The Role

Reporting to the Senior Director, Biostatistics, this position is responsible for collaboration with internal and external stakeholders to deliver the tactical execution of company's biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech company.

Key Responsibilities

• Serve as lead study biostatistician, providing statistical input into study design, sample size, protocol, statistical analysis plans, randomization plans, clinical study reports, and interpretation of statistical analysis results.
• Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers.
• Oversee biostatistics and statistical programming vendors to ensure quality, timeliness, and statistical integrity of deliverables.
• Represent Biostatistics on cross-functional study teams and develop effective collaborations with partner lines (such as Statistical Programming, Data Management, Clinical Development, Clinical Operations, and Regulatory).
• Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.
• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports.
• Apply innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.

Requirements

• PhD or MS in Statistics, Biostatistics, Mathematics, or related field
• 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area
• Knowledge of relevant FDA, EU, ICH guidelines and regulations
• Understanding of drug development
• Demonstrated ability to collaborate with diverse sets of stakeholders
• Strong written and oral communication skills with attention to detail
• Natural collaborator who enjoys working on a cross-functional team in a fast-paced, innovative environment

Work Environment

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required.

Salary range for posting: $180,000 USD - $200,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.