Manager Biostatistics (m/f/x)

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Date: 20-Nov-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

We are seeking highly qualified candidates to fill the position

 

Manager Biostatistics (m/f/x)

 

Manager Biostatistics is responsible, under supervision, to provide statistical support to Medical Affairs (MA) and Health Economics and Outcome Research (HEOR) / Health Technology Assessment (HTA). This includes support and/or ownership of study level deliverables such as study design, protocol development, statistical analysis plan (SAP), statistical analyses, interpretation of results, study reports and publications. Additionally, the position holder provides statistical expertise, and acts as main statistical contact for the assigned studies, with Study team(s). The position holder works closely with internal Data managers and statistical programmers, and is also responsible, under supervision, for CRO management and oversight. The position will either be based in one of our offices in Europe or from home within one of these countries. 
 

Roles and responsibilities:

Study level statistical activities

  • For all assigned studies, provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF; Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR); CRO coordination and oversight (if applicable)
  • Contribute, under supervision, to documents submitted to Health Authorities. May participate in meeting or teleconferences with Health Authorities
  • Ensure inspection readiness as well as prepare potential audits linked to assigned studies


Biostatistics activities to support Medical Affairs and HEOR/HTA strategies

  • Planning, set-up and execution of additional statistical analyses required for HEOR activities, HTA submissions and pricing/reimbursement negotiations, at global and local levels, including review of value dossier
  • Coordinate the statistical programmers involved in the development and execution of analyses HTA/HEOR activities
  • Contribute to the analyses of patient-reported outcomes (PROs) and Health Economic endpoints for clinical studies, from protocols review to analysis and interpretation
  • May participate in meetings with pricing authorities


Biostatistics activities to support scientific communication

  • Planning, set-up and execution of statistical analyses of clinical data required for scientific communications (publications, abstracts, posters, presentations)
  • Coordinate the statistical programmers involved in the development and execution of analyses for scientific communications
  • Provide guidance to Medical Affairs of the proper interpretation of statistical analyses for scientific communications


Evidence Generation Department Operational Excellence 

  • Ensure timely and accurate completion of biostatistical deliverables, including the oversight of external vendors
  • Continued effort to enhance methodological and statistical knowledge and ensure implementation of state-of-the-art statistical methodology
  • May contribute to departmental non-project Evidence Generation initiatives (e.g., to improve processes) 

 

Personal skills and professional experience:

  • Master’s degree or PhD (preferable) in statistics, mathematics or related fields
  • At least 2 years of experience as statistician supporting drug development and/or post marketing in a clinical research, Pharmaceutical or CRO setting
  • Experience in oncology Therapeutic Area and/or in late phase projects is an advantage 
  • Thorough and up-to-date knowledge of statistical methods related to clinical studies and/or to HEOR/HTA applications. Awareness of current developments in Real World Evidence (RWE) and/or Data-science methodologies is an advantage
  • Thorough and up-to-date working knowledge of SAS and/or R with hands-on programming experience. Knowledge of Python is welcome
  • Working knowledge of SDTM and ADaM data structure and CDISC standards
  • Good verbal and written communication skills, including ability to explain strategies, approaches, methods, analyses, and findings to non-statisticians
  • Excellent English language skills


 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.