Head of Biopharma Biostatistics

vor 1 Monat

Munich, Deutschland Emmes Vollzeit

Overview:
**Head of Biopharma Biostatistics - Remote**

**Germany Remote**

The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.

**Primary Purpose**

The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes’ biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others. The Head of Biopharma Biostatistics serves as a member of Emmes’ biopharma leadership team ensuring high-quality, on time, and on budget statistical deliverables and supporting business development activities for potential biopharma opportunities.

**Responsibilities**:

- Designs clinical development plans, clinical trial protocols, and statistical analysis plans in collaboration with our biopharma partners.
- Leads and oversees statistical deliverables including but not limited to execution of statistical analyses, interim safety and efficacy reports, clinical study reports, and scientific manuscript development.
- Fosters collaborative relationship with Sponsors and Emmes project team members serving as a point of contact for project statistical deliverables,
- Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings)
- Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC)
- Attends and presents at external statistical conferences and workshops serving as a thought leader in the biostatistics space.
- Proactively uses knowledge of advanced biostatistical methodology and leading industry trends to identify and implement biostatistical best practices.
- Responsible for successful delivery of biostatistics and statistical programming services to Emmes’ biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables.
- Collaborates with global department leadership to ensure sufficient resourcing to support Emmes’ biopharma portfolio
- Serves as an escalation point for biostatistics related client, quality or budget concerns for biopharma projects, resolving concerns or appropriately escalating to global biostatistics and biopharma leadership.
- Leads statistical only or limited scope projects including managing budgets, timelines, deliverables, and change orders
- Leads biopharma related business development activities on behalf of the global biostatistics department including but not limited to proposal, budget development, and bid defense support.
- Represents the global biostatistics department as a member of Emmes’ biopharma leadership team and serves as a member of the global biostatistics leadership team.
- Provides input into professional development and technical training standards for the global biostatistics department
- Independently leads cross-functional interactions and initiatives with other departments and global entities ensuring frequent, clear and open communication with groups outside the global biostatistics department.
- Effectively supervises biostatistics and statistical programming staff providing mentorship, feedback and conducting performance reviews
- Participates in recruiting activities for new biostatistics department staff and contributes to hiring decisions.
- Promotes staff participation and achieves a high degree of engagement across the global biostatistics department with a focus on staff supporting biopharma projects
- Proactively identifies high-performing staff and provides them with mentorship and opportunities for career growth
- Other duties as assigned

Qualifications:

- MS or PhD in Biostatistics, Statistics, or Epidemiology
- Typically has 12+years’ experience with a PhD or 15+ years

  • Head of Biostatistics and Data Science

    vor 1 Monat

    Munich, Deutschland Hobson Prior Vollzeit

    Hobson Prior are currently seeking for a Head of Biostatistics and Data Science to join a fantastic pharmaceutical corporation on a permanent basis with the ability to work remotely from anywhere in Germany. Our client is focused on providing the best possible assistance. Please note that to be considered for this role you must have the right to work in...

  • Principal Biostatistics

    vor 4 Wochen

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Director Biostatistics

    vor 1 Monat

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Director Biostatistics Rwe Eu

    vor 1 Monat

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Head of Medical Affairs, Adult Vaccines

    Vor 4 Tagen

    Munich, Deutschland GSK Vollzeit

    **Site Name**: Munich - Office **Posted Date**: Jan 10 2023 **Head of Medical Affairs, Adult Vaccines - Leiter Medical Affairs Erwachsenenimpfstoffe (m/w/d)** **Are you interested in a highly visible medical affairs role that allows you to **lead Medical Affairs Strateg**ies** for our** **Adult** **V**accine **P**ortfolio** and lead** **a diverse team of...

  • Head of Medical Affairs Pediatric Vaccines

    Vor 4 Tagen

    Munich, Deutschland GSK Vollzeit

    **Site Name**: Munich - Office **Posted Date**: Jan 10 2023 **Head of Medical Affairs, Paediatric Vaccines - Leiter Medical Affairs Pädiatrische Impfstoffe (M/F/d)** **Are you interested in a highly visible medical affairs role that allows you to **lead Medical Affairs Strateg**ies** for our** P**aediatric **V**accine **P**ortfolio** and lead** **a...

  • Head of UX/UI

    vor 1 Monat

    Munich, Bayern, Deutschland Project A Services Vollzeit

    Project A Services is hiring a Head of UX/UI in Munich Germany (April About the JobWe're looking for a customer-centric Head of UX/UI (m/f/d) to join one of our portfolio companies in Germany to drive the product vision and deliver exceptional user experiences that are backed by data and innovation. In your day-to-day work, you'll focus on optimisin

  • Head of Legal

    vor 1 Woche

    Munich, Deutschland Microsoft Vollzeit

    Microsoft is on a mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, a theme of inspiring excellence, and encouraging teams and leaders to bring their best each day. In doing so, we create life-changing innovations that impact billions of lives around the world. You can...

  • Head of Technology

    vor 4 Wochen

    Munich, Deutschland Skillsearch Limited Vollzeit

    Job reference - 14167 - Company Name - Skillsearch Limited - Salary - Location - Munich, Germany - Country - Germany - Industry sector - Programming - Job start date - ASAP - Posted date - 09/02/2023 - Experience Level - Not specified - Job type - Permanent | Full Time - Remote / Hybrid - No Skillsearch is helping a VR Games and Entertainment studio find a...

  • Head of Technology

    vor 4 Wochen

    Munich, Deutschland Skillsearch Limited Vollzeit

    Head of Technology - 14167 Skillsearch is helping a VR Games and Entertainment studio find a full-time Head of Technology in Munich. The role comes with an attractive salary and benefits package. As Head of Technology, you will be responsible for driving the development and implementation of cutting-edge virtual reality technology that meets the needs of...

  • Head of Data

    Vor 4 Tagen

    Munich, Deutschland Xcede Vollzeit

    **Posted**:about 10 hours ago- **Sector**: Data- **Location**: Munich- **Job Ref**: PR/118273_1685464313- **Job Type**: Permanent- **Salary**: €85001 - €130000 per annum + bonus, car per year- **Expiry Date**: 09 July 2023- **Contact**: Jordan Wright- **Head of Data - Munich - €130k + bonus**: Xcede have been engaged by a long-standing client,...

  • HiWi for "Implementation of a Head Mounted Display

    vor 1 Woche

    Munich, Deutschland Technical University of Munich Vollzeit

    HiWi for "Implementation of a Head Mounted Display (Augmented Reality) in the Rotorcraft Simulation Environment ROSIEX" 03.04., Studentische Hilfskräfte, Praktikantenstellen, Studienarbeiten Hours: 10-20 per week (negotiable) Background: At the Chair for Rotorcraft and Vertical Flight the Rotorcraft Simulation Environment ROSIEX is used for...

  • Head of Marketing

    vor 2 Wochen

    Munich, Bayern, Deutschland Richemont Vollzeit

    Head of Marketing & Sales Northern Europe and Nordics (m/f/d) HOW WILL YOU MAKE AN IMPACT? Within the Europe Team, the Head of Marketing & Sales develops PIAGET as a key actor of Jewellery & Watchmaking in the luxury industry in Richemont Northern Europe & the Nordics. He/she is responsible for Marketing and Sales activities on the region ensuring that...

  • Head of Sales

    vor 2 Wochen

    Munich, Deutschland Piper Maddox Vollzeit

    Piper Maddox are working with the world’s leading Aircraft Propulsion systems design and manufacturer to find an Head of Sales to join the business on a permanent basis. The company has been operating for the last 100 years and have now embedded itself as a world-class leader for power-dense, reliable and resilient Aerospace systems. They have five core...

  • Head of Global Finance

    vor 1 Monat

    Munich, Bayern, Deutschland Data Modul AG Vollzeit

    DATA MODUL ist einer der weltweit führenden Spezialanbieter für professionelle, industrielle Display-, Touch-, Embedded-, Monitor und Panel-PC Lösungen. Zur Verstärkung unseres Finance-Teams in unserer Firmenzentrale in München suchen wir Sie zum nächstmöglichen Zeitpunkt als Head of Global Finance (m/w/d).

  • Senior Associate Head of Production

    vor 1 Monat

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **Senior Associate Head of Production** **-** **230155** **UNSER UNTERNEHMEN** Bei Boehringer Ingelheim entwickeln wir bahnbrechende Therapien, die das Leben von Mensch und Tier verbessern. Als 1885 gegründetes und seitdem im Familienbesitz befindliches Unternehmen nehmen wir eine langfristige Perspektive ein. Mit 52.000 Mitarbeitenden weltweit setzen wir...

  • Head of Airworthiness

    Vor 7 Tagen

    Munich, Deutschland Storm4 Vollzeit

    ⚡ Position: Head of Airworthiness Industry: Aerospace Location: Bavaria, GermanyAre you passionate about aviation and ensuring the highest standards of airworthiness and safety? My client is looking for a dedicated professional to join their team as Head of Airworthiness. In this role, you will play a crucial part in maintaining compliance and guiding...

  • Head of Engineering

    vor 1 Woche

    Munich, Deutschland Storm4 Vollzeit

    Position: Head of Engineering Unternehmen: Innovative Lösungen im Bereich der Software- und Datenproduktentwicklung Standort: remoteBist du bereit für eine spannende Herausforderung bei einem führenden Unternehmen im Bereich Software- und Datenprodukte?Dann starte jetzt in deiner Rolle als Head of Engineering durch:⚡ Aufgaben:Führung und...

  • Head of Customer Support

    Vor 5 Tagen

    Munich, Deutschland FINN Vollzeit

    FINN makes mobility fun and sustainable. With a flexible car subscription, we bring a true e-commerce experience to car ownership and offset all CO2 emissions along the way. Join our fast-growing team to build the most popular auto e-commerce platform as we launch new product lines and expand internationally. We work with the best car brands in the world and...

  • Head of Actuarial

    vor 4 Wochen

    Munich, Deutschland Emerald Group Vollzeit

    Lead the group actuarial department and the active team lead of the solvency department. The function shall be responsible especially for the calculation and consolidation of the Group Solvency II process in terms of actuarial and risk processes. **Ref: 27584**: - ** Location**: Munich - ** Category**: International - ** Type**:...