Senior Manager Statistical Programming (m/f/x)

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Date: 31-Aug-2021

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

 

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

 

Senior 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:
 

 

  • Act as statistical programming lead, responsible for all the relevant programming activities (including but not limited to SDTM, ADAM and TFLs), including programming technical decision and may lead functional and/or multidisciplinary teams working on projects/studies and/or initiatives
  • Full independence on oversight of large-scale of external parties performing programming activities on behalf of DSE, including revision of contracts together with the development and oversight of external parties’ relationship
  • Accountable for statistical programming (PRO) deliverables and for ensuring excellence in programming activities in terms of quality, timelines, and budget for limited number of clinical
  • Ensures Programming deliverables meet/exceed project/ study team expectations regarding quality, time and cost and that programming documentation is filed/ archived according to applicable Daiici Sankyo and regulatory requirements
  • Provides full independent oversight of Statistical Programming and technical support to large 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
  • Promote and implement global data and programming standards
  • Participate in audits and inspections

 

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 8 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:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

 

Please apply online at our Career Portal. We are looking foward to hearing from you.