Biotech jobs in United States

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 ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a Principal Statistical Programmer in our multi sponsor business unit, you are central to the successful delivery of complex projects for renowned, innovative and global pharmaceutical and biotech companies.

This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas.

You can be 100% home-based in EMEA or you can work from our local office in your home country.

Your Responsibilities:

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
• Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
• Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
• Support/oversee submission activities
• Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
• Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes

Your Profile:

• Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company
• Solid experience with complex clinical trials (minimum 5 years) and the corresponding data sets content (safety and efficacy) and endpoints
• Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
• Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides and submission standards
• An autonomous, collaborative work style, a curious mind and a keen attention to detail
• Fluency in English - both verbal and written - is a must

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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.