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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As an expert Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. You will be responsible for all statistical programming deliverables of one or more complex clinical trials.
This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise as a Principal Statistical Programmer has a direct impact on improving the health and lives of thousands of patients around the globe every day. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!
You can be 100% home-based in any of the EMEA locations listed on this ad – or, if you prefer, you can work from our local office in your home country.
What else can you expect from us?
Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
A genuine work life balance
Flexibility in working hours
A thorough onboarding with support from your personal mentor
A permanent employment contract with Fortrea
Excellent training and career development opportunities, as well as support with advancing your individual education
Strong support from your Line Manager and your team, as well as from more than 20,000 Fortrea colleagues worldwide
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 and the client, etc.
Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform quality control reviews of SDTM, ADaMs and TFLs
Produce and/or 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 company 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-experienced team members in best practices around SDTMs, ADaMs and TFLs while 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 your expertise to proposal activities and bid defense
Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
Your profile:
Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for drug development
Profound professional experience as a lead statistical programmer working on complex studies within a biotech, CRO or pharmaceutical 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
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 Guide and submission standards
Solid experience with oncology and/or vaccine clinical trials and the corresponding datasets (safety and efficacy) and endpoints
Excellent organizational, time management and project management skills with demonstrated leadership skills
Outstanding problem solving and decision making skills, coupled with a proactive approach - anticipating issues and working to ensure they are avoided or resolved as quickly as possible
An autonomous, collaborative work style, a curious mind and a keen attention to detail
Business 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.
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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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