Principal Statistical Programmer (SAS/R) - Remote Pharma

Inserta Empleo

Burgos

Remoto

EUR 70.000 - 110.000

Tempo pieno

7 giorni fa

Candidati tra i primi

Aumenta le possibilità di ricevere una risposta da questo datore di lavoro

Il tuo curriculum e una lettera di presentazione personalizzati, che corrispondono esattamente a ciò che sta cercando.

Supera i filtri ATS

Descrizione del lavoro

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on global pharma projects. You will implement SDTM/ADaM, develop SAS/R programs, and oversee CRO deliverables with minimal supervision.

The role emphasizes regulatory submissions, Define.xml, FDA/ICH guidelines, and collaboration with cross-functional teams to deliver high-quality data outputs on time. Ideal candidates have 7+ years in biotech/pharma programming, strong SAS, CDISC standards, and excellent

Competenze

Bachelor's degree in CS/Math/Statistics/Data Science.
7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
SAS programming with CDISC SDTM/ADaM/Define.xml expertise.
Experience with regulatory submissions and FDA interactions.
Ability to work independently and lead CRO oversight.

Mansioni

Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
Develop SAS programs to generate datasets, listings, tables, and graphs.
Deliver high-quality SAS and/or R programming outputs for clinical programs.
Oversee CRO's programming deliverables across studies to meet timelines.
Support clinical study reports, regulatory submissions, publications, DSURs, and analyses.
Follow FDA regulations and good clinical practice for electronic submissions.
Contribute to standards for programming tools, outputs, and macros.
Develop CRFs, edit check specs, and data validation plans.
Review and/or author data transfer specifications for external data.