Job Description
Required Skills & Experience
Technical Skills
Expert‑level SAS programming
skills.
Strong, hands‑on experience with
CDISC SDTM, ADaM and TLFs .
Proven experience developing
safety, PK, and PK/PD ADaM datasets .
Experience supporting
POPPK/popPD/Exposure Response(ER) dataset creation
workflows.
Solid understanding of
early‑phase clinical trial designs , including:
Phase I / First‑in‑Human
Crossover studies
Exposure–response analysis
PK parameter pooling
Experience
8+ years of statistical programming experience in the pharmaceutical or CRO environment.
Demonstrated experience as a Lead Programmer or technical lead.
Prior experience working in an
FSP engagement model
preferred.
Experience supporting
regulatory submissions
is required.
Soft Skills
Strong communication and stakeholder management skills.
Ability to work independently while managing m...
Technical Skills
Expert‑level SAS programming
skills.
Strong, hands‑on experience with
CDISC SDTM, ADaM and TLFs .
Proven experience developing
safety, PK, and PK/PD ADaM datasets .
Experience supporting
POPPK/popPD/Exposure Response(ER) dataset creation
workflows.
Solid understanding of
early‑phase clinical trial designs , including:
Phase I / First‑in‑Human
Crossover studies
Exposure–response analysis
PK parameter pooling
Experience
8+ years of statistical programming experience in the pharmaceutical or CRO environment.
Demonstrated experience as a Lead Programmer or technical lead.
Prior experience working in an
FSP engagement model
preferred.
Experience supporting
regulatory submissions
is required.
Soft Skills
Strong communication and stakeholder management skills.
Ability to work independently while managing m...