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Ass. Director Bio-statistics - Innovative company - ONCOLOGY

Employer
NonStop Consulting
Location
Switzerland, Lausanne
Salary
Negotiable
Start date
8 Jan 2021
Closing date
15 Jan 2021

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Discipline
Data Management / Statistics, Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

My client is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from haematological malignancies and solid tumours. They have built a deep clinical and research pipeline of therapies for the treatment of cancers with significant unmet need. The Company has multiple antibody drug conjugates in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical antibody drug conjugates in development.

The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. There are operations in Lausanne Switzerland (Head office and Clinical), London UK (R&D), New Jersey US (Clinical and Commercial) and San Francisco US (CMC manufacturing).

As Associate Director in statistics you will be responsible for statistical activities in support of clinical trials outside of the US and report to Head of Global Biometrics based in New Jersey.

Job responsibilities:

  • At project level, you will ensure the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements;
  • Provide statistical support to Clinical Development Plan for multiple compounds;
  • Participate in pre-IND and NDA/BLA activities;
  • At study level, provide statistical input to study protocols, develop statistical analysis plan ;
  • Assist in writing relevant sections of the clinical study report and publication;
  • Monitor internal and CRO project activities including timelines, deliverables and resources;
  • Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary;
  • Develop and implement department standards and lead process improvements;

What we are looking for in a candidate:

  • PhD or MS in Biostatistics or Statistics;
  • At least four to six years' experience for PhD, or eight to twelve years' for MS, as statistician in Pharmaceutical or Biotechnology industries;
  • Good knowledge of statistical programming languages (including SAS, R);
  • Solid oncology and/or haematology experience
  • Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
  • Experience as an independent lead statistician with responsibility for multiple studies or projects
  • Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;
  • Knowledge of SDTM/ ADAM.

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!

Company

NonStop Consulting is an international recruitment consultancy renowned for a high level of service, professionalism, unrivalled industry knowledge and extensive industry networks.

With over 100 multilingual recruiters covering the life sciences industry across Europe, we take the time to get to know you – your wants, needs and aspirations. We then work tirelessly to match you with an employer that both matches your requirements and is the right cultural fit for you.

Underpinned by our in-house Quality Assurance team, our relationship with job seekers is fully transparent and truly consultative. Our recruitment consultants pay attention to every detail and pride themselves on being open and honest, ensuring the right opportunities for you as well as valuable feedback.

We are active members of APSCo, the Association of Professional Staffing Companies – a recognised badge of quality with the recruitment industry.

If you want to find out more about how we can help you, get in touch!

Company info
Website
Telephone
+41 (0) 435 080 817
Location
24 Poststrasse
Zug
6300
United Kingdom

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