Principal Biostatistician - FSP

Principal Biostatistician – FSP (Fortrea)

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 pharmaceutical and biotech companies.

You will be part of a long‑lasting partnership with one of our top sponsors (10‑year relationship) and work with over 150 people globally—from the US to APAC.

• Rewarding and meaningful work in an established, diverse, highly profitable, and respected global company
• Highly competitive compensation packages, including pension contributions, complimentary health insurance, remote working allowances, and other local benefits
• Strong work‑life balance and flexibility in working hours
• Thorough onboarding with support from a personal mentor
• Excellent training and career development opportunities, and support for advancing your education
• Ongoing support from your Line Manager, team, and more than 19,000 colleagues worldwide

• Lead complex studies such as New Drug Applications submissions or multi‑protocol programs, coordinating across multiple locations and providing statistical oversight in project meetings
• Perform project management activities for identified projects—resource planning, timelines, and milestone management
• Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings under the direction of Statistical Consultants
• Lead the development of complex Statistical Analysis Plans and perform senior review of plans created by other statisticians
• Conduct overall statistical review of Tables, Figures, and Listings for complex studies before client delivery
• Review Case Report Forms and other study‑specific specifications and plans
• Develop the statistical sections of the protocol for complex studies under supervision of a statistical consultant
• Prepare and review randomization specifications and generate randomization schedules
• Provide mentoring and training to less experienced staff and review departmental work for accuracy and adherence to policies
• Present and share knowledge at monthly seminars, team meetings, and external scientific meetings or conferences
• Attend bid defense meetings for complex studies
• Act as Subject Matter Expert and review procedural documents or work on new initiatives
• Represent the department during audits

• Degree in statistics, biostatistics, public health, or related field;
  Master’s degree strongly preferred
• 10+ years of experience as a Lead Biostatistician in biotech, CRO, or pharmaceutical settings
• Proficiency in SAS® and statistical procedures such as non‑parametric analysis, linear/non‑linear models, categorical data, and survival analysis
• Experience with SDTM, ADaM datasets, and TFLs
• Strong communication skills for explaining statistical concepts
• Comprehensive knowledge of the overall clinical trial process
• Competence in preparing Statistical Analysis Plans, analyses, and reporting across a variety of trials
• Excellent organizational skills, autonomous and collaborative work style, curiosity, and keen attention to detail
• Business fluency in English (verbal and written) – a must

• Office environment with exposure to electrical office equipment
• Occasional drives to site locations, both domestic and international travel
• Work may involve stationary periods of 6‑8 hours per day, repetitive hand movements, and occasional crouching, stooping, bending, and twisting of upper body and neck
• Ability to use computer software developed in‑house and off‑the‑shelf
• Light to moderate lifting (max 15‑20 lbs)
• Regular and consistent attendance is required; varied hours may be required

• Frequently stationary for 6‑8 hours per day
• Repetitive hand movement of both hands with fast, repeated finger, hand, and wrist movements
• Occasional crouching, stooping, frequent bending and twisting of upper body and neck
• Ability to access and use a variety of computer software in‑house and off‑the‑shelf
• Light to moderate lifting and carrying (max 15‑20 lbs)
• Regular and consistent attendance; varied hours may be required

USD 130,000 – 150,000 (base annual salary, US candidates only)

All job offers are based on skills, experience, and equity. Eligible full‑time or part‑time employees receive comprehensive benefits:
Medical, Dental, Vision, Life, STD/LTD, 401(k), ESPP, PTO/FTO, company bonus where applicable.

November 15, 2025.

Learn more about our EEO & Accommodations request here.

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