Staff Scientist, Biostatistics Projects

at  Thermo Fisher Scientific

Cambridge, MA 02139, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Jan, 2025Not Specified26 Oct, 20246 year(s) or aboveR,Clinical Trials,Statistics,Sas,Statistical Software,Drug Development,Bayesian Statistics,Statistical Concepts,English,Biostatistics,Scenario PlanningNoNo
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Description:

JOB DESCRIPTION

Role:

  • Statistical leader in the cross-functional development team of one compound/indication
  • Statistical expertise to the development strategy, decision making and interpretation of the data generated through the clinical development program, embracing excellence and innovation among quantitative methods
  • Closely collaborate with program partners and stakeholders to deliver on-time the statistical deliverables for all clinical trials and/or HA submissions of one compound/indication
  • Report to a disease area team leader, within the Biostatistics and Statistical Modelling organisation
  • Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements

Desired Skills, Qualifications and Experience:

  • Master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 6 years experience (which may include doctoral research in field of biostatistics)
  • Expertise in drug development in a regulatory environment, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
  • Experience in clinical trial design and scenario-planning
  • Extensive experience in the Pharma or Biotech environment
  • Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials
  • Expertise in Bayesian statistics
  • Proficient in statistical software (SAS and/or R);
  • Able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
  • Clearly explain complex statistical concepts in written and spoken English and not afraid to contribute and speak up when necessary
  • Team-player with focused attitude
  • Able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast growing biotech company with challenging timelines

What we offer:

  • Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
  • A work-environment in a human-sized, dynamic, rapidly growing biotech company
  • Next to a competitive salary with extensive benefits, we offer you the chance to grow and be a part of a team driven by creativity, innovation and science.

Responsibilities:

  • Statistical leader in the cross-functional development team of one compound/indication
  • Statistical expertise to the development strategy, decision making and interpretation of the data generated through the clinical development program, embracing excellence and innovation among quantitative methods
  • Closely collaborate with program partners and stakeholders to deliver on-time the statistical deliverables for all clinical trials and/or HA submissions of one compound/indication
  • Report to a disease area team leader, within the Biostatistics and Statistical Modelling organisation
  • Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirement


REQUIREMENT SUMMARY

Min:6.0Max:11.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Field of biostatistics

Proficient

1

Cambridge, MA 02139, USA