Senior Manager, Biostatistics

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September 18

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Genmab

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Biotechnology

Genmab is a biotechnology company focused on transforming lives through pioneering antibody science. The company is dedicated to developing innovative antibody therapeutics for various diseases, aiming to improve patient outcomes and treatment options. Genmab's efforts in antibody research and development highlight its commitment to advancing medical science.

1001 - 5000 employees

Founded 1999

🧬 Biotechnology

💰 $134M Post-IPO Equity on 2010-06

📋 Description

• Act as a biostatistician supporting the clinical development of compounds as compound lead and/or trial responsible statistician • Act as lead and main point of contact related to Statistics for designated compound/indication • Follow scientific and technical progress within the field of biostatistics and advise new methodologies • Engage with regulatory authorities on compound/indication and trial level discussions • Ensure consistency of statistical methods and data handling across trials • Provide scientific advice to the CDT including design of trials, analyses and advanced methodologies • Represent the CDT/the company at regulatory meetings, KOL meetings, and partner meetings • Drive design and synopsis development and ensure transparent communication to stakeholders • Ensure availability of integrated databases and planning/conduct of integrated analyses • Support development and communication of presentations, posters, and articles • Coordinate data transfers with partners and participate in vendor oversight and CTT activities • Review and provide input to protocol and amendment development, SAPs, CSRs, and other trial documentation • Perform exploratory, ad hoc analyses, modelling; review randomization plans and perform UAT of IRT systems • Support timely delivery of statistical deliverables and regulatory submission/filing activities

🎯 Requirements

• MS / PhD or equivalent in a statistical discipline • 5+ years of experience in relevant area preferred or demonstrated capability • Experience in statistical analysis, modelling and simulation and adaptive trial designs • Experience in working with clinical trials • Preferred experience with oncology clinical trials • Proficient programming skills in statistical software’s, such as SAS • Excellent oral and written communication skills • Ability to work independently as well as in teams • Confident, self-reliant, and a quick learner • Proactive and open-minded • Ability to prioritize and work in a fast-paced and changing environment • Result and goal-oriented and committed to contributing to the overall success of Genmab

🏖️ Benefits

• 401(k) Plan: 100% match on the first 6% of contributions • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses