#766-Sr Principal Statistical Programmer-Remote(Permanent role)

ClinChoice Inc.; Mississippi; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a talented Sr Principal Statistical Programmer to join their dedicated team. This role involves programming edit checks, creating clinical study reports, and leading programming groups to ensure high-quality data management. With a commitment to professional development and a collaborative culture, this opportunity offers a fulfilling career path where your contributions can significantly impact the clinical research landscape. If you are passionate about making a difference in healthcare and have a strong background in clinical programming, this position is perfect for you.

Qualifications

• 10+ years of clinical programming experience with SAS.
• Strong understanding of clinical drug development processes.

Responsibilities

• Program edit checks for Data Management using SAS.
• Create tables and figures for clinical study reports.

Skills

SAS Programming

Clinical Programming

Data Management

Leadership Skills

Communication Skills

Education

Bachelor’s degree in Computer Science

Master’s degree in Computer Science

Tools

SDTM specifications

ADaM specifications

define.xml

Study Data Reviewer’s Guide

Job description

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Sr Principal Statistical Programmer on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Responsibilities

Key responsibilities and skills may include, but are not limited to:

1. Programming edit checks for Data Management with SAS.
2. Create tables, listings and figures for clinical study report.
3. Independently annotate blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
4. Create or QC SDTM specifications and SDTM datasets.
5. Create or QC ADaM specifications and ADaM datasets.
6. Create or QC define.xml or define.pdf.
7. Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
8. Serve as team leader for one/more Programming groups.
9. Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.
10. Manage and coordinate the integration of data across studies in support of ISS and ISE and electronic submission deliverables.
11. Follow industry standards and be a mentor to other Programming leads or managers.
12. Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.
13. Be a role model for team members.

Qualifications

1. Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ years clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ years of clinical programming experience.
2. Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
3. Good understanding of the clinical drug development process.
4. Detail oriented.
5. Strong communication and coordination skills.
6. Good leadership skills.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you meet the requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. Close management and training are the core instruments to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this as our strength and celebrate it.

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