Associate Director, Biostatistics

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $180k - $200k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 2%

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Immunovant

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

📋 Description

• 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 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 collaborate with Statistical Programming, Data Management, Clinical Development, Clinical Operations, and Regulatory • Ensure study-level statistical activities comply with relevant regulatory requirements and Immunovant standards • Plan, deliver, and communicate statistical analyses, data presentations, and scientific reports • Apply innovative statistical methodology to streamline clinical development and facilitate optimal decision-making • Report to the Senior Director, Biostatistics

🎯 Requirements

• PhD or MS in Statistics, Biostatistics, Mathematics, or related field • 5+ years of experience in biotechnology, pharmaceutical or health related area; 7+ years for MS • 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

🏖️ Benefits

• Equity and other forms of compensation may be provided as part of a total compensation package • Medical benefits • Dental benefits • Vision benefits • 401k • Unlimited paid time off • Parental leave • Remote-based work environment

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