Biostatistician as Evidence Manager - Electronic Health Records (f/m/d)

ZipRecruiter; Heidenheim an der Brenz; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a dedicated RWD/RWE Manager to lead strategies focused on real-world data. The role involves collaboration with various teams to generate clinical evidence and ensure compliance with regulatory standards. The position offers flexible working conditions and significant opportunities for professional growth.

Leistungen

Flexible working conditions

International mobile working options

Childcare subsidies

30 days paid leave annually

Company pension plan

On-site amenities

Access to fitness and wellness programs

Job Bike leasing

Qualifikationen

• At least 3 years of experience in generating RWD and RWE.
• Proven experience with real-world data sources.
• Strong knowledge of GDPR and data privacy laws.

Aufgaben

• Design and implement RWD and RWE strategies.
• Collaborate with cross-functional teams.
• Lead data extraction and analysis from diverse sources.

Kenntnisse

Project Management

Statistical Programming

Communication Skills

Data Analysis

Health Economics

Ausbildung

Advanced Degree in Epidemiology, Biostatistics, or Related Fields

Tools

SAS

R

Python

Jobbeschreibung

Job Description

At HARTMANN, we're committed to helping, caring, protecting, and growing. We support healthcare professionals so they can focus on what truly matters: positively impacting people's lives. We develop solutions that make a difference. With your dedication, you can grow professionally every day. At HARTMANN, we believe in the impact you can make.

Join our team as

RWD/RWE Manager (f/m/d)

Location: DEU-Heidenheim

We are seeking a highly skilled and motivated Real-World Data (RWD) / Real-World Evidence (RWE) Manager to join our Evidence Department. The successful candidate will lead the development and execution of RWD and RWE strategies to support clinical, regulatory, and market access efforts for our medtech products. This role is essential in translating real-world insights into evidence that informs healthcare decisions and promotes the adoption of innovative medical technologies.

Currently, we are conducting several RWD comparative effectiveness studies using data from the EU/UK and the US.

Responsibilities:

1. Design and implement RWD and RWE strategies to generate clinical, safety, and economic evidence for medtech products.
2. Collaborate with cross-functional teams within the Evidence Department (Clinical Trials, Evidence Synthesis, Health Economics, Diagnostic/Prognostic Research), and beyond, including regulatory, clinical affairs, market access, marketing, and sales to integrate RWE into product development and lifecycle management.
3. Develop study protocols for observational studies, registries, and post-market surveillance to gather and analyze real-world data.
4. Lead data extraction, cleaning, analysis, and interpretation from diverse real-world data sources such as electronic health records (EHR), claims data, patient registries, and wearables.
5. Communicate RWE findings through reports, scientific publications, white papers, and presentations to internal stakeholders, regulatory authorities, and external audiences.
6. Ensure compliance with applicable regulatory guidelines and industry standards for data privacy, security, and ethical use of patient data.
7. Stay updated with emerging trends and technologies in real-world data and evidence, and apply innovative methods to optimize RWD and RWE strategies.

Qualifications:

1. Advanced degree in epidemiology, biostatistics, health economics, public health, data science, or related fields.
2. At least 3 years of experience in generating RWD and RWE, preferably in medtech, pharma, or healthcare.
3. Proven experience with real-world data sources (EHR, claims, registries) and RWE studies for regulatory or HTA purposes.
4. Experience working with various RWD types and causal inference methods.
5. Proficiency in statistical programming and analysis tools (SAS, R, Python) and familiarity with RWD platforms (e.g., Flatiron, IQVIA).
6. Strong knowledge of real-world study designs (retrospective cohort, case-control, registry-based) and global regulatory requirements (FDA, EMA).
7. Expertise in GDPR, data privacy laws, and health economic models with evidence synthesis.
8. Strong project management and communication skills, with experience in medtech or digital health solutions.

Benefits:

• Flexible working conditions, including flexible hours and remote work.
• International mobile working options.
• Support for work-life balance, such as childcare subsidies.
• 30 days paid leave annually, plus additional leave for special life events, vacation pay, and annual bonuses.
• Company pension plan with employer contributions and matching for deferred compensation.
• On-site amenities including parking, canteen with café bar, and employee shop discounts.
• Access to over 6,000 fitness and wellness studios via EGYM Wellpass.
• Health and fitness programs, including screenings, online mental health courses, massages, and yoga.
• Job Bike leasing and discounts on travel, fashion, and technology through our corporate benefits platform.