.

Manager/Sr. Statistical Programmer

  • Boston, MA
scheme imagescheme imagescheme image

Company Background

MorphoSys is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies.
 
Over the last two decades, MorphoSys has forged partnerships with many of the leading global pharmaceutical companies. Together with our global partners, we have developed more than 100 product candidates, of which 27 are currently in clinical development – one of the broadest pipelines in the industry.
 
In 2021, Constellation Pharmaceuticals Inc, became a fully owned subsidiary of Morphosys. Constellation Pharmaceuticals Inc is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics. 
 
Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.com or www.morphosys-us.com or www.constellationpharma.com. We are #BolderAndBrighterTogether!

Job Summary & General Responsibilities

  • Oversight and QC of CRO activities in:
    • SDTM and ADAM Datasets development
    • Table / Listing / Figure (TLF) development and validation based on the Statistical Analysis Plan
    • TLF Mock shells development
  • Working with data management in providing programming support for DM activities including data review
  • Performing ad-hoc programming activities utilizing raw data based on internal and external requests
  • Contributing in process development, reviewing and development of SOPs related to statistical programming activities
  • Participate in Clinical Trial Teams, Data Review Teams, etc., and provide inputs from statistical programming perspective
  • Communicating with and/or responding to internal cross-functional teams and clients for project specifications, status, issues or inquiries
  • Collaboration with Statisticians and Data Management in planning study activities and ensuring study timelines are met
  • Performing lead duties when called upon

Job Qualifications, Experience & Skills

  • Ideally three or more years of experience in a Pharmaceutical company or a CRO as a SAS Programmer 
  • Bachelor´s or Master´s degree in Informatics, Mathematics, Medical Documentation or other relevant qualification
  • Excellent ability in SAS data manipulation, analysis and reporting skills
  • Extensive experience in implementing CDISC SDTM, CDISC ADaM, and Define standards
  • Good knowledge of Table / Listing / Figure (TLF) programming, including SAS / STAT and SAS macro language and SAS graphic features
  • Good understanding of descriptive and inferential statistics
  • Proficient in industry standards, medical terminology and clinical trial methodologies
  • Submissions experience utilizing define.xml and other submission documents is a plus
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Good communication skills and a good command of English language
  • Ability to work under pressure, flexibility and adaptability
Location
  • Boston, MA

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.