Manager Statistical Programming

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.

For our European Headquarter in Munich or other affiliates in Europe we are looking for a

Manager Statistical Programming (m/f/x)

The position:

The position holder will manage, with direction, end-to-end delivery of Statistical Programming ser-vices for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.

The position holder will partner with internal and external stakeholders to optimize Statistical Pro-gramming technology, processes, and standards.

The position will have a working knowledge of Statistical Programming applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.

Roles & responsibilities:

Study level statistical activities

Responsible, with supervision, for study activities assigned to Statistical Programming including but not exclusive to SAPs and TFL shells review from a programming perspective, contribute to develop specifications for SDTMs and ADaM datasets, contribute to develop and validate SAS programs to create SDTM and ADaM datasets and TFLs, demonstrate knowledge with XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs

Ensure timely and accurate completion of Statistical Programming deliverables

Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities

Must comply with international regulations and maintain inspection readiness

Ensure inspection readiness as well as prepare potential audits linked to assigned studies

Vendor Oversight

With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other rele-vant guidelines

Participates in drafting request for proposal for CRO selection. Reviews base-line budget and time-lines. Contributes to budget management and activities across the project duration

Operational Excellence Innovation

Participate in Global Evidence Generation 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 Programming methodology 

Any other duties deemed pertinent to the needs of the business.

Professional experience & education:

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; master’s degree in bio/statistics preferred

At least 2 years of experience supporting drug development and/or post marketing in clinical re-search, Pharmaceutical, CRO or Medical Device setting 

Experience in oncology Therapeutic Area and/or in late phase projects is an advantage

Competencies and Generic Skills

Excellent English language skills 

Good understanding of GCP and GDPR principles

Good communication skills, both oral and written, in explaining in simple terms complex concepts

Advanced working knowledge all SAS language, procedures and options commonly used in clinical tri-al reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. Knowledge of SAS Enterprise Guide and/or SAS Studio is recommended but not required

Previous experience supporting SAS macro and/or system utility development is preferred

Solid knowledge of new advanced statistical methods using SAS

R knowledge is highly recommended but not required

Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clini-cal Research.

Fundamental negotiation and project management skills