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Senior Clinical Statistical Programmer
hace 3 semanas
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.
Summary of Responsibilities:
- 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviews Guides to support SDTMs and ADaMs.
- Develop specifications for SDTMs and ADaM datasets.
- Review SAPs and TFL shells from a programming perspective for studies.
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs.
- Present and share knowledge at department meetings.
- Respond to QA and client audits, and support qualification audits.
- Identify processes within programming that will increase productivity, quality, and efficiency.
- 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.
- Language Skills Required: Speaking: Yes, English required Writing/Reading: Yes, English required
Experience (Minimum Required):
- Typically, 3-5 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.
- Knowledge of CDISC requirements.
Physical Demands/Work Environment:
- Office or home-based environment, as requested by the line manager.
- Travel Requirements: Yes.
- Local, Domestic, Regional.
- % of time: Approximately 5%.
- % of the above that requires overnight stay: Approximately up to 100%.
- Travel is primarily to where: client meetings and trainings.
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
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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