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Associate Director, Biostatistics

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Associate Director, Biostatistics

Pharmaceuticals

New Jersey, USA

Description

Associate Director, Biostatistics

This is a genuinely fantastic opportunity to be part of a new team being built within early clinical development but part of a wider statistics group. You'll be working at a strategic level within most early phase development including Rare disease, diabetes and rare blood disorder as well as others.

You'll have minimal direction from the group head and you will provide your leadership and guidance on projects in early clinical development (including Proof of Concept studies) and
prepare regulatory submissions. You will be accountable for all methodological and statistical aspects of projects in order to optimise their early development plan.

Role

*You'll be leading several early-phase projects across various therapeutic areas
*Lead and execute clinical trials, from the study trial design, analysis planning, study results presentation and interpretation, up to clinical study report, regulatory submissions and
*publications (including by coordinating some statisticians/contractors or oversight CROs)
*Participate in meetings with regulatory authorities; prepare submission dossier
*You'll be writing clinical development plans, clinical study synopsis/protocols, interpreting statistical analyses, and presenting results
*Provide/develop statistical expertise within the team, department or cross-function with pharmacology, pharmacokinetics or pharmacometrics teams.


Experience

*Principal, Lead or AD level Biostatistician within a Pharma or Biotech company ideally early Clinical development (Phase I and II ) Otherwise late phase experience but with a keen interest in early clinical development
*Ability and proven track record in leadership of clinical trials and exceptional communication skills both locally and within a global team
*You'll have leadership experience within a Pharma or Biotech company
*You'll be adept within statistics used in the pharmaceutical industry in clinical development including statistical methods used for flexible designs as well as simulation techniques
*Any biomarker experience is a plus but not essential


This really is a fantastic opportunity to join a newly created team within early clinical development which tends to move faster with greater regulatory flexibility. There are open discussions around development options every year and career options within the company.


You'll need the right to work in the USA and be available to go onsite up to 2 days a week in New Jersey, USA. If you are looking for an exceptional challenge to be part of a brand new growing team with Global support, please get in touch today for a confidential discussion.
 

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Job Details

  • Job Type:

    Permanent
  • Salary:

    US$160k - US$190k per annum + plus 15-20% bonus + benefits
  • Job published:

    26 days ago
  • Reference:

    BBBH8657