818#Senior Statistical Programmer/Analyst II

ClinChoice Inc.; Mississippi; On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking global CRO as a Senior Statistical Programmer/Analyst II, where you'll play a vital role in clinical development. This advanced position involves developing datasets and analysis for clinical studies, ensuring compliance with FDA guidelines, and collaborating with statisticians to drive innovative solutions. With a focus on quality and teamwork, this role offers a rewarding opportunity to impact lives positively. If you're passionate about data analysis and clinical research, this is the perfect chance to advance your career in a supportive environment that values professional growth and work-life balance.

Qualifications

• 5+ years of clinical programming experience required.
• Proficient in high-level computing languages and programming logic.
• Strong understanding of clinical research and regulatory requirements.

Responsibilities

• Develop SDTM and ADaM datasets using SAS based on specifications.
• Create electronic submission packages for FDA compliance.
• Lead programming teams and mentor junior members.

Skills

SAS

C/C++

Java

R

Python

MATLAB

SQL

Artificial Intelligence

Machine Learning

Microsoft Office Suite

Education

Bachelor’s/Master’s degree in Statistics

Bachelor’s/Master’s degree in Mathematics

Bachelor’s/Master’s degree in Computer Science

Bachelor’s/Master’s degree in Electrical Engineering

Bachelor’s/Master’s degree in Biotechnology

Job description

818#Senior Statistical Programmer/Analyst II

United States

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 Senior Statistical Programmer/Analyst IIon a permanent basis.

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

Job Summary

This is an advanced-levelSenior Statistical Programmer/Analyst II position. Key responsibilities and skills may include, but are not limited to:
• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
• Develop SDTM specifications and generate SDTM datasets using SAS.
• Develop ADaM, specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
• Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
• Analyze information and develop innovative solutions to programming and data analysis challenges.
• Actively communicate with statisticians for statistical input and analysis interpretation.
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Qualifications

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 5 years of clinical programming experience.
• Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
• Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
• Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Detail-oriented and ability to learn and adapt to changes.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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.

Who will you be working for?

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 and close management and training is the core instrument to develop and maintain highly-qualified personnel. The 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 is our strength and celebrate it.

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