Farmacie & Geneesmiddelen Vacatures in Edam Volendam

Over de vacature

Overview

In this role you drive the end-to-end external data management for clinical trials, leading data acquisition from external providers and ensuring data quality and integration. You will partner with cross-functional teams to align data collection with trial objectives and regulatory standards. You shape external data strategies, governance, and vendor oversight to enable timely, analysis-ready data. This role offers the chance to impact oncology trials within a science-driven, collaborative culture and to mentor other data professionals.

Arbeidsvoorwaarden / Benefits

• 401(k) plan with match
• health, dental, and vision insurance
• paid vacation, sick leave, holidays, parental leave
• backup care and family support programs
• tuition reimbursement
• Lifestyle Spending Account

Verantwoordelijkheden

• Lead external data acquisition across studies/programs with high-quality, timely data aligned to trial objectives
• Advise on external data collection design and integration feasibility with CDASH/SDTM and EDC requirements
• Plan and oversee external data flow strategies and data transfer systems across diverse data types
• Collaborate with cross-functional stakeholders to ensure data acquisition supports operational and scientific goals
• Develop and manage Trial Data Integrity Plans (TDIP) and data flow documentation
• Create and maintain DTS requirements; ensure vendor data aligns with SDTM and clinical database needs
• Review external vendor budgets and change orders; act as escalation point for complex vendor issues
• Mentor junior External Data Acquisition Leads and lead cross-functional initiatives
• Partner with procurement/legal to review contracts and ensure alignment with Genmab standards
• Promote consistency and scalability through training, knowledge sharing, and strategic planning

Belangrijkste vereisten

• 10+ years in external or clinical data management with strong third-party vendor oversight

• Experience on Oncology trials/data and governance of DTS and complex data flows for EDC integration

• Knowledge of diverse external data types (biomarker, central lab, imaging, eCOA/ePRO, genomic) and alignment with objectives

• Experience managing projects, vendors, and process improvements in global environments

• Proven performance in a prior role

• collaboration

• leadership

• mentoring

• CDISC standards (CDASH, SDTM)

• EDC (electronic data capture) systems

• TDIP and data flow management

Over de vacature

Overview

In this role you lead statistical strategy and execution for designated compounds/indications in early and late-stage programs. You engage with regulators, ensure consistent statistical methods across trials, and drive integrated data analyses to support development decisions. You contribute to trial design, analysis plans, and regulatory meetings, acting as a key scientific advisor within the CDT and trial teams. This position offers the chance to shape how Genmab advances pioneering antibody medicines that aim to transform patient outcomes. You will work in a collaborative, data-driven environment that values scientific rigor and impactful cancer therapy development.

Arbeidsvoorwaarden / Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health benefits: medical, dental, vision
• Paid time off: vacation, sick leave, holidays; discretionary parental leave
• Voluntary plans: critical illness, accident, hospital indemnity
• Backup care and family support programs
• Tuition reimbursement and Lifestyle Spending Account

Verantwoordelijkheden

• Act as lead and main Statistics contact for designated compound/indication
• Stay current with biostatistics developments and advise on innovative methodologies
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Share compound/indication related work among biostatisticians and with vendors
• Support integrated database specification development with the programming team
• Provide statistical input to overall CDT strategy and synopsis development
• Advise on trial design, analyses, and advanced statistical techniques within CDT
• Represent CDT/company at regulatory meetings, KOLs, and partner meetings
• Drive design and synopsis development with stakeholders
• Ensure integrated databases availability and plan integrated analyses for development decisions
• Support development and communication related to presentations, posters, and articles
• Attend and present at meetings, congresses, and courses for professional networking
• Ensure biostatistician reviews of protocols, SAPs, results meetings, and trial reports
• Coordinate data transfers with partners alongside programmers and data managers
• Apply state-of-the-art statistical methods with solid scientific foundation
• Maintain proper documentation and oversee QC of vendor data and analyses
• Ensure trial work complies with Genmab SOPs, processes, and ICH-GCP
• Participate in regulatory data package discussions with Data Monitoring Committees
• Contribute to data integrity, transparency, and timely delivery of statistical deliverables

Belangrijkste vereisten

• Master's or PhD in statistics or a related field

• 8+ years of relevant experience preferred

• Experience in statistical analysis, modeling, simulation, and adaptive trial designs

• Biologics, targeted therapies, and companion diagnostics exposure preferred

• Experience with FDA, EMA, and ICH guidelines for statistics in drug development

• Experience with regulatory submissions (BLAs) and interactions with health authorities

• Proficiency with SDTM, ADaM, eSUB, and CDISC for regulatory submissions

• Track record of managing multiple complex projects in a technical role

• Proven ability to work with cross-functional teams and vendors

• Strong communication and leadership skills

• collaboration

• communication

• leadership

• statistical methods for drug development

• adaptive trial designs

• regulatory statistics