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Principal Biostatistician

  • 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

  • Responsible and accountable for the statistical activities and support on statistical solutions for studies/publications and conferences and support the tasks independently seeking peer inputs/ reviews as required. Activities include protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
  • Perform trial statistician activities to ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures.
  • Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scientific analytical solutions.
  • Oversee Biostatistics resources and deliverables for assigned trials and therapeutic area level. Lead study teams to ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
  • Explain statistical methodology and interpret analysis results. Provide statistical expertise to support all activities and documents, meetings with and responses to customers and JOC meeting activities, as required.
  • Maintain efficient interfaces with Global Program Statistician, internal and external customers.
  • Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians, and provide adequate statistical justifications for actions/decisions/statements, when required.
  • Participate in non-clinical project activities as needed. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings.

Job Qualifications, Experience & Skills

  • MS/ MSc (in Statistics or equivalent) with 5 or more years relevant work experience or PhD (in Statistics or equivalent) with 2 or more years of work experience
  • Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software.
  • Good understanding of global clinical trial practices, procedures, methodologies and deep knowledge of data architecture
  • Statistical and numerical knowledge and expertise in analytic aspects and applications in clinical trials.
  • Comprehensive knowledge and prior experience of advanced statistical methodology in clinical trials that apply to Phase I-IV clinical trials, adaptive study design, Bayesian analysis and regulatory requirements relating to clinical development of drugs
  • Ability to initiate, drive and implement novel methods and innovative trial designs, including the development and review of study related documents (e. g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter)
  • Profound knowledge of statistical software “Base SAS”, “SAS Macros”, “Addplan” and “R”
  • Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards / imple­men­tation guides, 21 CFR Part 11, and FDA guidelines
  • Expertise in medical research, especially oncology and inflammatory diseases
  • Experience in calculating probability of study success, modelling and simulation
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines
  • Experience in working in matrix organizations
  • Team player with well-developed interpersonal abilities
  • Excellent written and oral communication skills in English, including grammatical / technical writing skills
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.