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Associate Director, Biostatistics

  • Boston, MA
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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

  • Lead strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, statistical deliverables) from multiple therapeutic areas. Perform these tasks with a high level of independence seeking peer input/review, as required.
  • Initiate, drive and implement novel methods and innovations in study designs and data analysis. Contribute to planning and execution of exploratory analyses, innovative analyses, exploratory biomarker analyses, co-author publications, and statistical consultation.
  • Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, statistical reviews and recommendations to Business Development & Licensing (BD&L), and other drug development activities, as required.
  • Actively participate as a statistical expert with external review boards/ethics committees, external consultants, steering committees, and other external parties with oversight, as appropriate.
  • Represent Biometrics on cross-functional teams for the assigned studies and projects. Establish and maintain sound working relationships and effective communication within the study teams and Biometrics team.
  • Independent oversight and timeliness of all Biostatistics deliverables and ensure quality of these deliverables. Collaborate cross-functionally (e.g., with data management, statistical programming, medical writing, and CROs) to ensure timeliness and quality of statistical deliverables.
  • Participate in CRO qualification and selection processes. Guide relevant CRO personnel regarding

Job Qualifications, Experience & Skills

  • PhD (in Statistics/Biostatistics) with 5+ years relevant work experience or MS (in Statistics/Biostatistics) with 8+ years relevant work experience.
  • Fluent in English (oral and written), strong interpersonal, presentation and communication skills.
  • Demonstrated excellence in use of statistical software packages (e.g., R, SAS).
  • Effective utilization of innovative statistics and quantitative analytics to influence project team decisions and support department to achieve objectives. Strong track record in the development and evaluation of modern study design methodologies.
  • Proven knowledge and expertise in statistics/biostatistics and its application to clinical trials and observational studies. Depending on the assignment, may require proven expertise in exploratory biomarker, applied Bayesian statistics, or data exploration skills.
  • Strong knowledge of drug development and Health Authority guidelines. Strong understanding of multiple therapeutic areas.
  • Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates.
  • Good business ethics.
Health & Safety
  • Full vaccination against COVID 19 is a requirement for this position.
Culture & Benefits
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success. 

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.