Principal Statistical Programmer (Oncology), FSP

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.

Hiring for Principal Statistical Programmer, (Oncology) FSP: These permanent, remote opportunities can be worked anywhere in U.S. or Canada regions

Are you ready to discover your extraordinary potential at Fortrea?A career here provides the unique chance to create a lasting impact and difference in patients' lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative workplace, along with access to comprehensive benefits.

Job Overview:

• Perform the role of the Lead Statistical Programmer
• 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 and the client, etc
• Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
• Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Labcorp Drug Development and Client standards
• Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
• Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes
• Present and share knowledge at department meetings
• Respond to QA and client audits and support qualification audits
• Contribute to proposal activities and participate in bid defenses meetings in order to win new business
• Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
• And all other duties as needed or assigned

Qualifications (Minimum Required):

• Bachelor's degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects
• Experience and/or education plus relevant work experience, equating to a Bachelor's degree
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Experience (Minimum Required):

• Typically, 6 years of SAS programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• Experience as lead statistical programmer on complex studies in clinical research
• Needs Oncology lead experience. Typically, 3-5 years of Oncology experience
• Submissions experience is preferred
• Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards

US Pay Range:$110,000 - $145,000 USD

Benefits: All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/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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