Senior Director, Statistical Innovation

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $223.6k - $302.6k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 senior advisory input on therapeutic-area and product-development strategies, development programs, and clinical studies • Drive evaluation and selection of conventional and innovative study designs, estimands, and estimators • Advise senior stakeholders on complex statistical and methodological issues affecting development decisions, regulatory interactions, and filings • Synthesize and interpret simulation results, regulatory considerations, operational feasibility, and development objectives • Provide specifications to the Simulation and Modeling team and develop, review, and approve simulation plans and results • Connect insights and lessons across products and programs to promote consistent application of innovative design and analysis approaches • Advise Biostatistics TA leaders, GSLs, and EGTs on product strategy, program design, and clinical study design • Direct, apply, interpret, and communicate modeling and simulation with quantitative partners • Review study design options, proposals, development plans, Phase 2 and Phase 3 protocols, and governance submissions • Build strategic partnerships with biostatistics leaders, strategic development, GSLs, EGT functional leaders, FSC members, and senior stakeholders • Promote innovative designs and analysis methods across products and programs • Sign off the simulation plan • Produce design options for ECP, design simulation plans, design and simulation tools, and detailed study-specific designs

🎯 Requirements

• Doctorate degree and 5 years of Statistics/Biostatistics or related subjects with high statistical content, OR Master’s degree and 9 years, OR Bachelor’s degree and 11 years • At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • At least 12 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting • Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions • Strategic statistical leadership at product level of at least one complex program or multiple programs of moderate complexity • Expertise in statistical principles, methods, and procedures relating to randomized and non-randomized clinical research • Ability to propose and apply innovative study design and advanced statistical methods • Expertise in advanced statistical analysis methods, modeling and simulation • Knowledge of disease areas and regulatory guidelines • Experience leading regulatory and/or reimbursement submissions • Strong oral and written communication skills • Strong influencing and negotiating skills • Excellent business acumen and strategic thinking • Ability to manage multiple projects and prioritize • Ability to lead without direct authority • Ability to navigate a large global organization and build partnerships with FSC and EGT members

🏖️ Benefits

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance plans