Principal Statistical programmer

Responsibilities:

SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy).

If applicable, develops and provides department training for applications and standard tools developed by the department functions group.

CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs).

Study Lead: Experience juggling multiple projects simultaneously is preferred.

Submission Documents: You'll create and review submission documents and electronic case report forms (eCRTs).

Collaboration: Effective communication with cross-functional teams and clients is crucial.

Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review.

Requirements:

Expertise: Familiarity with statistical principles, CDISC data, and standards.

Proficiency in SAS programming skills in a clinical data environment with excellent. analytical skills. Knowledge of other programming languages such as R, Python etc.

Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus.

SAS, (Base, Stat, Macro, graph); SAS certificates a plus.

Minimum MS/MA degree in Biostatistics, Statistics, Computer Science, or a related field.

At least 5 years of experience working as a Statistical Programmer or Data Scientist.

Ability to synthesize results in graphic, oral, and written reports.

Exceptionally strong statistical programming in SAS and R.

Experience programming in other languages, such as SQL, Matlab, Python.

Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical.