Manager Statistical Programming (m/f/x)

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Date: 26-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.

 

For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

Manager Statistical Programming (m/f/x)

The position:
 

The position is accountable for statistical programming (PRO) deliverables and for ensuring excellence in programming activities in terms of quality, timelines and budget for clinical projects or studies under his/her responsibility. Providing the oversight as well as technical support to project teams on all statistical programming deliverables and programming submission. Develop Daiichi Sankyo programming efficiency by developing tools and macros and enhance standard on SDTM/ADaM datasets and TFLs.

 

Roles and responsibilities:

 

  • Lead oversight of Statistical Programming and technical support to limited number of third party vendors (CROs) on all statistical programming deliverables (including, but not limited to, SDTM, ADaM and TFLs) to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines
  • Under supervision, responsible to oversight limited number of external parties performing programming activities on behalf of DSE, including revision of contracts together with the development and oversight of external parties’ relationship
  • Ensure high quality and efficiency of all Programming related tasks performed by external providers or by internal staff
  • Interact with (Senior) Management to resolve programming issues in projects/ studies and/or programs and provide hands-on statistical programming support to regulatory and market access submission and help submission team in quick turnaround in response to regulatory agencies
  • Support building up DSI compound specific programming standard on datasets and TFLs to improve efficiency and quality
  • Develop Daiichi Sankyo programming efficiency by developing tools and macros and enhance standard on SDTM/ADaM datasets and TFLs
  • Responsible for proper and clear communication and subsequent handling of Programming issues/tasks within project teams

 

Personal skills and professional experience:
 

  • Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master’s degree in bio/statistics preferred
  • At least 5 years of proven experience within pharmaceutical life science industry or CROs supporting statistical analysis of clinical trials programming
  • Previous experience supporting SAS macro and/or system utility development is highly preferred
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming
  • Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis 
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials
  • Having knowledge of all phases of drug development, including early and late phase clinical development and submission
  • Having solid background of applied statistics
  • Solid knowledge of new advanced statistical methods using SAS and R
  • Knowledge in database structures and set-up

 

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.