Director Biostatistic 100%

  • SFL Regulatory Affairs & Scientific Communication
  • 4051 Basel, BS, Switzerland
  • 16/05/2022
Full time Data Science Data Analytics Statistics Biostatistics DevOps

Job Description

Job details

Job Type
Full-time
90-100%

Full Job Description

Would you like to join and contribute to an award-winning, successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry?

SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

We have an opening for a Director Biostatistic located in Switzerland or EU or the UK.

Core responsibilities

  • Direct management of Biostatistics managers and indirect management of all Biostatistics staff, including personnel development, growth, training, and leading department meetings
  • Responsible for department financials
  • Resourcing and project staffing, interviewing, hiring, and handling personnel issues
  • Lead and/or participate in corporate compliance activities as it relates to biostatistics, including development and review of department policies, SOPs
  • Ensure that Biostatistics project responsibilities are completed accurately and timely
  • Contribute to the continuous improvement of the department
  • Stay abreast of latest developments in the field of statistics in drug development
  • Collaborate with all other department functional heads, including statistical consulting
  • Attend meetings with scientific advisory groups and regulatory bodies, as needed, to support statistical aspects of regulatory submissions on behalf of sponsors
  • Provide statistical consultation on issues related to the design, analysis, and interpretation of clinical trials in a variety of therapeutic areas
  • Plan, coordinate, and provide statistical analyses, summaries, and reports of studies in the support of product development including IND/NDA and BLA submissions

Qualifications and requirements

  • PhD or Masters in Statistics, Biostatistics, math-related discipline, with applied statistics training, with 10 (ten) years of relevant work experience
  • Minimum of 5 years of experience in personnel management
  • Thorough knowledge of ICH, GCP guidelines and other applicable regulatory rules
  • Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff
  • Excellent written and oral communication skills including grammatical/technical writing skills
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently as well as in a team environment
  • Experience with regulatory agencies, such as the FDA or EMA
  • Skilled in use of computer technology, including SAS, and ability to learn new applications

SFL offers

  • A stimulating role in an award winning company (Great Place To Work)
  • Active contribution to registration of innovative products
  • Continuous development and external educational trainings for each team member
  • Work in an energetic, motivated team
  • Rewards for outstanding accomplishments

About SFL

We provide innovative and customized services and solutions in the life science field from offices in Switzerland, EU and the UK.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation. We are a rewarding company with an excellent environment to grow.

Please send your application with CV, motivation letter and references only via email to hr_sfl@sfl-services.com (no paper applications or phone calls).