Principal Stats Programmer

5 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.

Job Description:
- Act as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)- Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity- Review and interpret Statistical Analysis Plans and provide comments for assigned projects. Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with mínimal supervision- Representing Statistical Programming at internal project team meetings, client meetings and audits- Contribute to proposal activities and client presentations providing time and cost estimates for statistical programming activities- Perform ongoing review of hours for assigned projects, ensure all issues are highlighted and resolved as quickly as possible and ensure all non-contract tasks are identified, tracked and included in change order forms

Qualifications (Minimum Required):- 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, 7 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.- 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.

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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