See more Collapse

Principal Biostatistician

2 months ago

London, United Kingdom Lifelancer Full time

Our Senior Biostatisticians perform adhoc orexploratory analyses to support submission or Health AuthorityQuestions. Having exposure to regulatory work experience is a bonusfor example if you understand the regulatory questions andtranslating them to statistical problems collaborating effectivelywith clinical and regulatory colleagues. Supporting mediumcomplexity clinical trials (starting from Design to Archivalexperience) and supporting some projectlevelactivities.
As a Principal Biostatisticianyour responsibilities willinclude:

  • Providingstatistical support to clinicalstudies
  • Participating in the development ofstudy protocols including participation in study design discussionsand sample size calculations
  • Reviewing CRFs anddata review guidelines; developing statistical analysis plans(SAPs) including analysis dataset and TLGspecifications
  • Performing statistical analysesand interpreting statistical results
  • Preparingclinical study reports including integrated summaries forsubmissions
  • Utilizing your strong communicationskills to present and explain the methodology and consequences ofdecisions.


Tobe successful in this position you willhave:

  • Masters degree instatistics or a related discipline. Ph.D. stronglydesired.
  • 8 years supporting clinical trials inthe Pharmaceutical or Biotechnologyindustry.
  • Experience working for a CRO isstrongly desired.
  • Experience in sample sizecalculation protocol concept development protocol development SAPand preparing clinical study reports including integrated summariesfor submissions.
  • Good SAS programming skillsfor QCing critical outputs Efficacy/Safety tables and workingclosely with Programmers. Knowledge of R programming is aplus.
  • Solid understanding implementation ofCDISC requirements for regulatorysubmissions.
  • Adept in ADaM specificationsgeneration and QC of datasets
  • The ability tobuild strong external internal relationships and motivate aregional or global team.
  • Very effectivecommunicator: able to explain methodology and consequences ofdecisions in lay terms.

Please usethe below link for job application and quickerresponse.

RemoteWork :

No

We have other current jobs related to this field that you can find below

  • Senior Biostatistician

    4 weeks ago

    London, United Kingdom Luminary Group Full time

    Luminary Group is currently seeking a skilled and dedicated Principal Biostatistician to join our client. As a Biostatistician, you will play a crucial role in providing statistical support and expertise for research studies and clinical trials. You will collaborate with cross-functional teams to analyze, interpret, and report study data, contributing to the...

  • Principal Biostatistician

    1 month ago

    London, Greater London, United Kingdom Cytel Software Full time

    Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...

  • Principal Biostatistician

    2 months ago

    London, United Kingdom Novartis Full time

    **Summary**: 15 months rotating across 3 key areas of the Novartis Analytics OrganizationNovartis continues to accelerate its growth in the data and digital space. As part of our continued growth, we are hiring PhD Graduates into our Analytics community who will start their career with 15 months rotating across 3 key areas of the organization. You will have...

  • Principal Biostatistician

    4 days ago

    London, United Kingdom Advanced Group Full time

    A Principal Biostatistician is responsible for directing assigned projects and providing statistical support for clinical trials. This includes generating randomization schedules, participating in protocol and SAP development, preparing and reviewing programming specifications used in creating derived datasets, tables, listings, and figures, and reviewing...

  • Principal Biostatistician

    4 weeks ago

    London, United Kingdom MMS Holdings Inc. Full time

    Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention...

  • Real World Principal Biostatistician, Hybrid

    2 months ago

    London, United Kingdom Vertex Full time

    Job DescriptionGeneral Summary:The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company's Real World Statistics area with some guidance and mentoring on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired...

  • Senior Medical Director

    7 days ago

    London, United Kingdom GlaxoSmithKline Full time

    Site Name: UK – London – New Oxford Street, UK - Hertfordshire - StevenagePosted Date: Jul 19 2024PLEASE NOTE CLOSING DATE: Monday, August 5th, 2024 at midnight US time.Are you a physician scientist keen to progress your oncology pharma career in the innovative and exciting field of ADCs? If so, this Senior Medical Director career opportunity within...