As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Senior Biostatistician, Oncology FSP (Remote): This permanent, remote opportunity can be worked from anywhere in the U.S.
We are seeking Senior Biostatistician to lead large global or other major projects, analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients including tracking project activities and project time management. The selected candidate will provide statistical input into other disciplines’ activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes; supervise and train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Analysis Plans including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and mockups.
Essential Job Duties:
- Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
- Conduct overall statistical review of TFLs for complex studies prior to client delivery
- Review CRF and other study specific specifications and plans
- May perform sample size calculation for simple studies under the supervision of more senior statistical staff
- Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
- Provide statistical input and review of the CSR for medium complexity studies Preparation and review of randomization specifications and generation of randomization schedules
- Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
- Present and share knowledge at team meetings and/or at monthly seminars Attend bid defense meetings for medium complexity studies in order to win new business
- Represent the department during project-driven client audits.
Minimum required:
- Recommended: Master's degree, equivalent, or higher in Biostatistics or related field
- Required: Bachelor’s degree, equivalent, or higher in Biostatistics or related field
Minimum Required:
- 5-8 years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
- Needs minimum 2 years of Oncology experience across Phase I, II, III (solid state tumors and RECIST background)
- Experience with Survival Analysis, Stat lead experience for NDA submission studies. Submissions experience preferred
- 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
- Ability to effectively communicate statistical concepts A good knowledge of the overall clinical trial process
- Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
US Pay Range: $115,000 - $145,000 USD
Benefits: All job offers will be based on a candidate’s 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. For more detailed information, please click here. Application deadline is November 15, 2024.
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Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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