Biostatistics Director – Oncology Biosimilars

🔥 2 minutes ago

🌽 Illinois, New Jersey, +4 more states – Remote

🌽 Illinois – Remote 🏖️ New Jersey – Remote 🦀 Maryland – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $200.1k - $270.7k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide strategic statistical input for clinical development from early to late phase across multiple products and therapeutic areas • Develop and maintain statistical excellence in the design, analysis, and reporting of biosimilar development • Contribute to clinical development plans • Review clinical development plans, regulatory documents, study synopses, protocols, SAPs, flash memos, CSRs, submission documents, health-authority correspondence, and clinical publications • Hire, allocate, manage, and develop internal statistical staff • Develop and execute statistical strategies for clinical development programs • Ensure standards, technical quality, and consistent approaches in study design and statistical analysis • Provide statistical input into regulatory strategies, presentations, scientific reports, clinical trials, regulatory submissions, product defense, market support, and publications • Represent the statistical function in meetings with regulatory authorities, key opinion leaders, and specialist bodies • Provide oversight and mentorship to Amgen staff and CROs on study deliverables, timelines, and quality standards • Support development and review of policies, SOPs, and controlled documents • Provide subject matter expertise in statistical methodologies • Publish applied research and present statistical methodology at external scientific meetings • Stay current with scientific advances and update internal practices • Develop and maintain relationships with statistical opinion leaders in academia, regulatory agencies, and industry

🎯 Requirements

• Doctorate degree and 4 years of Biostatistics experience OR Master’s degree and 8 years of Biostatistics experience OR Bachelor’s degree and 10 years of Biostatistics experience • Master’s or Doctorate degree in Mathematics, Biostatistics or Statistics preferred • Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations • Deep knowledge of statistical methodology and applications within drug development, especially in oncology • Knowledge of statistical methodology and applications within drug development • Statistical leadership to regulatory submissions • Effective written and oral communication and presentation skills, including statistical strategy • Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs • Experience with adaptive designs, including group sequential design, treatment arm selection adaptations, Bayesian adaptive design, and/or combined phase 1/2 or phase 2/3 design • Life cycle drug development experience from pre-clinical development through clinical development and post-marketing • Demonstrated leadership attributes and a track record developing high-performance teams • Experience working within a global team and with CRO partners • Ability to work in the U.S. excluding Puerto Rico; sponsorship is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support