Principal Statistical Programmer (Remote)

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.

• Principal Statistical Programmer required to work for Fortrea as an experienced Lead Statistical Programmer on studies in Phases I-II
• You will be employed by Fortrea and work within our FSPx department 100% dedicated to one Sponsor
• You must have previous experience as a Lead Statistical Programmer within a biotech, CRO or pharma company
• Opportunities to develop and progress

Discover new opportunities to grow your career as a Fortrea Principal Statistical Programmer. Our partner has an incredibly exciting and strong pipeline with over 30 ongoing oncology studies in Phases I and II. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise whilst gaining exposure to a pharmaceutical working environment this is a fantastic opportunity.

This is an incredibly exciting time to be joining Fortrea as we continue to grow and expand.

As a Fortrea employee dedicated to a project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance. An opportunity to match your area of expertise.

Each project offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Fortrea studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

Job Primary Functions

• 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 Covance 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

Job Qualifications

• Degree, preferably in computing, life science, mathematical or statistical subject
• Experience as lead statistical programmer on complex studies in clinical research company
• 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
• Candidates must be fluent in English language (both verbal and written)

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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