Principal Biostatistics (m/f/x)

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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 protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are looking in our European Headquarters in Munich or in our affiliates in Europe (remotely also possible) for a:
Principal Biostatistics (m/f/x) The Position
  • The position holder will manage, with limited direction, Biostatistics study activities assigned, to support non-R&D functions, and ensure high quality deliverables are on time and within budget.
  • The position holder will partner with internal and external stakeholders to optimize Statistical methods, processes and standards.
  • The position holder will act as main statistical contact for the assigned study activities, in particular in cross-functional Study team(s).
Role & Responsibilities
  • Responsible for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR)
  • Support Medical Affairs and HEOR/HTA strategies: Set-up additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and health economic endpoints; Review or co-author the value dossier and scientific communications.
  • Contribute to documents submitted to regulatory or pricing authorities.
  • May participate as subject matter expert in meeting or teleconferences with health authorities.
  • Responsible for providing direction and execute oversight of vendor delivery
  • May lead and/or participate in departemental initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
  • Maintains current knowledge of industry best practice in statistical methodology.
  • May act as subject matter expert for statistics representing the department in cross-functional teams.
  • Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.
Professional experience & education:
  • Master’s degree or PhD (preferable) in statistics, mathematics or related fields.
  • At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting.
  • Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
  • Strong knowledge of major statistical methods within industry standards
  • Proficiency on handling CDISC standards and statistical software such as but not limited to SAS and R
  • Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
  • Demonstrated expertise in study design, conduct and execution
  • Excellent English language skills
  • Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
  • Demonstrated entrepreneurship and leadership and proactive problem solving
  • Ability and interest to work remotely with worldwide team members across cultures
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information: www.daiichi-sankyo.eu

What we offer

  • Excellent Benefits
  • Work-Life-Balance
  • Growth and Development
  • Health and Wellbeing Support

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Daiichi Sankyo Europe GmbH
Daiichi Sankyo Europe GmbH

Current Openings: 0

Daiichi Sankyo is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people around the world by leveraging our world-class science and technology. In Europe, we want to become the benchmark for customer centricity in the areas we work in and a competitive player in Oncology. For these reasons we are constantly looking for new talents that are willing to deliver the best solutions to the various healthcare professionals who aim to provide their patients with the best possible therapy - whether in the cardiovascular or oncological field. We know that our success in Europe relies on courageous people who seize opportunities and turn them into results. This is why we encourage our teams across Europe to be passionate about their objectives, challenge conventional thinking and share their local recipes for success and learnings with the whole company. It is only through their input, ideas and honest feedback that we can learn and leverage the full potential of our company. In Europe we are operating in 13 countries. Because of our rather small size compared to larger pharmaceutical companies, each of our employees can have a huge impact – whether they work in the medical area, sales force, business intelligence or the IT department. This is why everybody at Daiichi Sankyo rolls up their sleeves and gets things done, even if this means that they sometimes have to go beyond their usual duties. If you would like to be an active member of our European family, we highly appreciate your application. Please take a look at our current vacancies. Imprint: https://www.daiichi-sankyo.eu/meta-navigation/imprint All information posted by Daiichi Sankyo Europe on this channel is intended for non-US, non-Canada & non-UK visitors.
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