Principal Biostatistician FSP

Cytel

$125K — $150K *
US-AnywhereRemote in Cambridge, MA
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • PhD or equivalent degree in statistics/biostatistics or related field with 3+ years experience, or Master's with 6+ years experience.
  • Proven ability to work independently and lead projects with initiative and flexibility.
  • Strong attention to detail and quality focus, coupled with exceptional interpersonal and communication skills.
  • Proficiency in SAS programming for quality control and statistical reporting.

Responsibilities

  • Lead statistical activities for Clinical Trials from protocol design to results reporting.
  • Represent the Statistics function on cross-functional trial teams, ensuring collaboration with stakeholders.
  • Oversee programming activities and contributions from internal teams or CROs on clinical trials.
  • Contribute to or lead statistical activities, including Safety Reporting and addressing queries from Health Authorities.
  • Utilize SAS and/or R for data quality checks and various statistical analyses.
  • Engage in additional initiatives at Cytel or sponsor side as needed.
  • Provide oversight and mentorship to junior Statisticians when required.

Benefits

  • Comprehensive training and development opportunities.
  • Supportive work environment focused on employee success.
  • Opportunities for involvement in cross-functional projects.
Full Job Description
Job Description

Position Overview:

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

Responsibilities

As a Principal Biostatistician, your responsibilities will include:
  • Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
  • Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
  • Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
  • Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
  • Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
  • Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
  • Oversight of more junior Statisticians as needed.


Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

  • PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master's degree with a minimum of 6 years relevant work experience.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
  • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours.
  • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.

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