For our headquarter 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:

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.