Job details

959#Lead Statistical Programmer Analyst (Full-Time, Remote – Any Therapeutic Area)

ClinChoice is a global full-service CRO dedicated to professional development and quality-focused collaborative culture. They are seeking a dynamic Lead Statistical Programmer/Analyst with expertise in clinical programming to join their remote team and contribute to clinical trial data analysis and reporting.

Skills

Proficiency in SAS for clinical data programming.
Knowledge of high-level computing languages such as C/C++, Java, R, Python, MATLAB, and SQL.
Ability to decode programming logic and explain to team members.
Experience applying Artificial Intelligence and Machine Learning concepts.
Strong understanding of Good Clinical Practices and clinical trial process.
Proficient in Microsoft Office Suite.

Responsibilities

Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
Develop SDTM and ADaM specifications and generate datasets using SAS.
Create Tables, Listings, Graphs, and Patient Profiles for Clinical Study Reports and other documents.
Develop datasets for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
Prepare electronic submission packages to FDA following regulatory guidelines.
Analyze data programming challenges and develop innovative solutions.
Communicate actively with statisticians for analysis interpretation.
Follow and reinforce regulatory agency requirements daily.
Serve as programming team lead, provide guidance, mentoring, and training.
Review production deliverables to ensure quality and consistency.

Education

Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Engineering, Biotechnology or related scientific disciplines.

Benefits

Professional development opportunities.
Supportive collaborative culture with work-life balance focus.
Opportunity to work remotely with a global team.
Commitment to diversity and inclusion.

To read the complete job description, please click on the ‘Apply’ button

Lead Statistical Programmer SAS Clinical Data CDISC FDA submissions SDTM ADaM Clinical trials Statistical programming AI Machine Learning

ClinChoice Glassdoor Company Review

3.7

ClinChoice DE&I Review

3.6

CEO of ClinChoice

John D. Balian

Approve of CEO

Average salary estimate

$130000 / YEARLY (est.)

min

max

$110000K

$150000K

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ClinChoice

Our mission is to be a valuable partner to our clients by providing a wide variety of services for product development and regulatory submissions. We continuously strive to raise the standard of excellence through accuracy and efficiency. This re...

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FUNDING

Private

DEPARTMENTS

Data Analysis

SENIORITY LEVEL REQUIREMENT

Senior Level

INDUSTRY

Pharmaceutical

TEAM SIZE