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Senior Consultant/ Principal Consultant Biostatistics (Advanced Analytics)

United Kingdom, Remote Additional Locations: Slovakia; Bucharest, Bucureşti, Romania; Dublin, Dublin, Ireland; Madrid, Madrid, Spain; Milan, Milano, Italy; Prague, Czechia; Vilnius, Lithuania; Warsaw, Poland Job ID R0000009934 Category Regulatory / Consulting Date Posted 03/29/2023
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Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Relationship-builder
  • Results-driven
  • Strategic

About This Role

Our Advanced Analytics team is expanding and we are recruiting for a Senior Consultant or Principal Consultant Biostatistician. We are looking lead for experienced lead biostatisticians with familiarity with primary observational data studies.  Working knowledge of CDISC standards and R will be a plus.

Position Overview

You will work independently in reviewing protocols, developing SAPs (including mock shells), developing data specifications per CDISC standards, programming and quality control of derived datasets and statistical outputs,  production of reports, and providing statistical advice to study teams and clients.

Objectives of the role will include:

  • Acting as Lead Biostatistician to interact with the study team and the sponsor

  • Drafting statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedules per study design and relevant specifications

  • Reviewing case report forms (CRFs), data management plans, data specifications, and other related study documents

  • Independently developing statistical analysis plans

  • Preparing specifications for CDISC and other analysis datasets

  • Independently developing SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan

  • Performing QC of TLFs, CDISC and other analysis datasets

  • Reviewing study protocols and providing input to statistics section

  • Providing statistical input to Clinical Trial Reports

  • Aiding business development with statistical considerations for new study bids, preparing biostatistics budgets, and attending bid defense meetings

  • Serving as a mentor to junior-level biostatisticians to help develop skills

Qualifications

  • Expertise in primary observational studies

  • Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications 

  • Familiarity with specifications for CDISC and other analysis datasets

  • Strong statistical programming skills with standard software, including SAS and R

  • Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly

  • Ability to communicate effectively, in non-technical terms, with project team members

  • Ability to work well in a team as well as independently and take leadership roles with regard to methodological elements in projects

Education and Experience

Master's or Doctoral Degree in Statistics, Biostatics, Mathematics, Data Science or other quantitative fields. 

Language Skills

Competent in written and spoken English

Computer Skills

SAS (Base, Stat, Graph, Macro) and R


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