Statistical Programmer 1

6 months ago

Bengaluru Karnataka, India Fortrea Full time

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.

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 Reviewers 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

Required Skills: ADAM, TLF OR SDTM, ADAM OR SDTM, TLF OR SDTM, ADAM, TLF:
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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