Senior Manager, Epidemiology

Jobtailor; Deutschland; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an epidemiology-focused professional to collect and analyze data for regulatory submissions and forecasting. You will work with clinical development, medical affairs, biostatistics, and regulatory teams to deliver study plans and reports.

The role involves coordinating outsourced studies, identifying data sources, and presenting findings to stakeholders while ensuring regulatory compliance and high-quality deliverables.

Qualifikationen

• Advanced degree in epidemiology or related discipline.
• At least 2 years in pharma, CRO, or academia.
• Experience with rare disease studies.
• Experience coordinating cross-functional processes.
• Experience analyzing secondary data sources (claims, EMR).
• Excellent English communication.
• Biostatistics and epidemiology knowledge.

Aufgaben

• Identify and analyze epidemiology data for regulatory submissions.
• Lead outsourced epidemiology studies and manage CROs.
• Provide data for forecasting and commercial planning.
• Develop and maintain secondary data sources (claims, EMR).
• Coordinate cross-functional teams and timelines for studies.
• Present findings at congresses and co-author manuscripts.
• Ensure compliance with regulations and guidelines.

Kenntnisse

Epidemiology

Biostatistics

Data Analysis

Project Management

Regulatory Submissions

Remote Work

SAS/Stata/R

SEER Data

Ausbildung

MS/MPH/MSPH/PhD in Epidemiology

Tools

SEER*Stat

SAS

Stata

R

MS Word

MS Excel

MS PowerPoint

Jobbeschreibung

• Conduct or outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, demographics, co-morbidities, treatment patterns and concomitant medications
• Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs and other processes requiring epidemiological data
• Provide top of the patient funnel data for forecasting and commercial purposes
• Identify appropriate US and EU secondary data sources, including administrative claims and EMR databases
• Lead Requests for Proposal and Statements of Work for outsourced epidemiology studies
• Support multi-disciplinary non-interventional Phase IV study teams and deliver study-related regulatory submissions
• Develop statistical analysis plans with project biostatisticians
• Manage external investigators, project managers and operational leads at CROs and Data Providers
• Communicate with US and EU Regulatory Leads regarding submission deliverables and PMR/PMC timelines
• Develop partnerships with Clinical Development, Medical Affairs, Biostatistics and Regulatory Affairs stakeholders
• Communicate study plans, timelines, budgets, progress reports and study results to internal teams
• Present research findings at scientific congresses and co-author peer-reviewed manuscripts
• Ensure compliance with applicable laws, regulations and regulatory guidelines

Requirements

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)
• At least 2 years of experience in the pharmaceutical industry, CRO or in academia
• Experience with rare disease studies
• Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
• Experience successfully coordinating cross-functional processes
• Experience analyzing secondary data sources (administrative claims and EMR databases)
• Excellent oral and written communication skills in English
• Solid understanding of epidemiology and biostatistics
• Experience managing multiple projects and reprioritizing work when necessary
• Capable of working remotely with minimal supervision
• Proficiency with MS Word, Excel and PowerPoint
• Ability to travel approximately 10% time
• Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
• Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
• Experience conducting post-marketing safety studies of marketed medicines
• Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company
• Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities
• Data analysis programming skills (SAS, Stata, R) or recent hands‑on experience using an RWE platform technology

Core Competencies

Demonstrates expertise in epidemiology and biostatistics, with a strong background in managing cross-functional projects and regulatory submissions. Proficient in data analysis and communication, with experience in the pharmaceutical industry and therapeutic areas such as oncology.

Highest-signal resume keywords

• Epidemiology Data Analysis
• Regulatory Submissions
• Project Management
• Data Analysis Programming (SAS, Stata, R)
• Oncology Therapeutic Area Experience

Hard Skills

• Epidemiology
• Biostatistics
• Data Analysis
• Project Management
• Secondary Data Analysis
• Protocol Authoring
• Study Report Writing
• Post-Marketing Safety Studies
• Site-Based Data Collection
• Forecasting

Soft Skills

• Excellent Communication Skills
• Cross-Functional Coordination
• Adaptability
• Remote Work Capability

Certifications & Qualifications

• Advanced Degree in Epidemiology or Related Discipline

Industry Keywords

• Pharmaceutical Industry
• CRO
• Clinical Development
• Regulatory Affairs
• EMR Databases
• Administrative Claims
• Non-Interventional Studies
• Rare Disease Studies
• Clinical Drug Development
• Health Authorities

Tools & Technologies

• MS Word
• MS Excel
• MS PowerPoint
• SEER*Stat
• RWE Platform Technology