Lead Statistical Programmer

Company Description

MEDTEK AI is a data science-driven company dedicated to accelerating drug development and delivering innovative healthcare solutions. Our team comprises experts in statistics, data science, statistical modeling, programming, data visualization, cloud data engineering, and regulatory submissions, among other areas. We collaborate with pharmaceutical and biotech companies across North America, Japan, and the European Union. MEDTEK AI is committed to excellence, innovation, and supporting our partners in advancing global healthcare.

JD of Principal Statistical Programmer

Responsibilities:

Project lead level activities.

Performs data analysis using primarily the SAS programming language for the summary

and interpretation of clinical trial data.

Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic

Submission from the data received in non-standard form from various sources.

Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and

graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

Review Data Management Plan, Data validation plan and edit check specifications

Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate

outputs according to the requirements.

Implements and contributes to statistical analysis plans; provides additional expertise in

the analysis of clinical trial as it relates to protocol development, case report form design

and data collection.

Recognizes inconsistencies and initiates resolution of data problems.

Exercises independent judgment in developing methods, techniques and evaluation

criteria for obtaining results.

Works on significant and unique issues where analysis of situations or data requires

evaluation of intangibles.

Acts independently to determine methods and procedures on new assignments.

May provide guidance to other lower level personnel.

Works closely with Biostatistics to create analysis files specifications following the

instructions provided in Statistical Analysis Plan (SAP)

Develop SAS coding and table templates for preparing, processing and analyzing clinical

data.

Create/acquire tools to improve programming efficiency or quality.

Establish monitoring of data transfers for ongoing trials to identify study conduct or data

quality issues.

Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

Experience:

Minimum 12 years Pharmaceutical/Biotech programming experience.

NDA submission experience and knowledge required.

Strong SAS programming and Statistical background along with experience with SAS Base,

SAS/Macros, SAS/Graph and SAS/Stat.

Education Requirements (degree, certifications, etc.): Include must have and preferred

BS/MS in Statistics, Math or Scientific Discipline.