Principal Biostatistician FSP

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit you are central to the successful delivery of complex clinical trials for renowned innovative and global top pharmaceutical and biotech companies.

In this role you will develop and review Statistical Analysis Plans for data presentation analyses and provide programming support to your multidisciplinary global project team.

About the team

You will be part of a long-lasting partnership with one of our top sponsors (a 10-years relationship) for which we pride ourselves on being the preferred provider.

In this team you will work with over 150 people globally all with great experience and ready to support you at any given time since we work globally from the US to APAC.

What else can you expect from us

• Rewarding and meaningful work in an established diverse highly profitable and respected global company
• Highly competitive compensation packages including various local benefits such as pension contributions complimentary health insurance plans remote working allowances etc.
• A genuine work life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor
• Excellent training and career development opportunities as well as support with advancing your individual education
• Strong support from your Fortrea Line Manager and your team as well as from more than 19000 colleagues worldwide

Your responsibilities:

• Lead complex studies such as New Drug Applications submissions or complex multi-protocol programs potentially coordinating activities across multiple locations providing statistical oversight and attending relevant project meetings
• Perform project management activities for identified projects including resource planning timelines and milestone management
• Serve as Data Monitoring Committee Support Statistician developing DMC Charters and attending DMC Meetings under direction of Statistical Consultants
• Lead the development of complex Statistical Analysis Plans perform senior review of statistical analysis plans developed by other statisticians
• Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
• Review Case Report Form and other study specific specifications and plans
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• Preparation and review of randomization specifications and generation of randomization schedules
• Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies practices and procedures
• Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
• Attend bid defense meetings for complex studies
• Act as Subject Matter Expert and develop or review procedural documents or work on new initiatives
• Represent the department during audits.

Your profile:

• Degree in a relevant field such as statistics biostatistics public health etc. Masters degree strongly preferred.
• Solid experience (10 years) of working as a Lead Biostatistician in either a biotech CRO or pharmaceutical company
• Ability to program in one or more statistical software packages (SAS) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g. non-parametric analysis linear and non-linear models categorical data and survival analysis
• Proven professional experience with SDTMs ADaM datasets and TFLs
• Proven ability to effectively communicate statistical concepts
• A good knowledge of the overall clinical trial process
• Competence in the preparation of Statistical Analysis Plans analysis reporting etc. across a variety of trials
• Strong organizational skills an autonomous and collaborative work style a curious mind and a keen attention to detail
• Business fluency in English both verbal and written is a must

Physical Demands/Work Environment:

Work Environment:

• • Work is performed in an office environment with exposure to electrical office equipment.

  • Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• • Frequently stationary for 6-8 hours per day.

  • Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.

  • Occasional crouching stooping with frequent bending and twisting of upper body and neck.

  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

  • Regular and consistent attendance.

  • Varied hours may be required.

Pay Range: $130000-$150000 USD base annual salary (US Candidates only)

Benefits: All job offers will be based on a candidates skills and prior relevant experience applicable degrees/certifications as well as internal equity and market data. Regular full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(K) ESPP Paid time off (PTO) or Flexible time off (FTO) Company bonus where applicable.

The application deadline is October 31st 2025.

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