Principal Biostatistician

  • Boston, MA
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Company Background

At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.

Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.

Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.

To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

Job Summary & General Responsibilities

  • Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy
  • Lead the development of the statistical analysis plan for clinical trials and historical control comparisons
  • Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data
  • Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results for CSRs / ISE / ISS
  • Provide guidelines and standards to CROs to ensure quality of deliverables
  • Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA / ICH guidelines, Good Clinical Practices, and regulatory requirements
  • Contribute to interactions with external review boards / ethics committees, external consultants and key opinion leaders
  • Contribute in process development including writing SOPs and mentor junior members of the team
  • Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings

Job Qualifications, Experience & Skills

  • Masters in Statistics or Mathematics with 3+ years of experience working in a Pharmaceutical Company or a Biotech or a CRO or PhD in Statistics or Mathematics with 2+ years of experience working in a Pharmaceutical Company or a Biotech or a CRO
  • 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 is an essential requirement: (two weeks after completing the second dose of a two-dose COVID-19 vaccine e.g., Pfizer or Moderna or two weeks after receiving a single dose of a one-dose vaccine e.g., Johnson & Johnson/Janssen

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.