Principal Statistical Programmer/Analyst Consultant Remote

ClinChoice; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

ClinChoice is seeking a Principal Statistical Programmer Consultant to join one of our clients. This client-facing role requires independence and a high-trust relationship with the sponsor.

The candidate will contribute to data management, analysis, and reporting across studies within a project and collaborate with CROs and vendors. The position emphasizes extensive SAS programming expertise, CDISC data standards, and experience in FDA-regulated environments, with responsibilities including CRF

Qualifications

• Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience.
• Expertise in SAS programming language, report generation, and standards for programming and validation.
• Therapeutic area- Rare Disease.
• Experience With CDISC Data Standards Required.

Responsibilities

• Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings.
• Produce data listings, summary tables, and graphics for interim and final analyses.
• Integrate data across studies within a project. Test, document, review, and validate all programs according to department guidelines.
• Coordinate data transfer and/or programming standards with CROs and vendors. Validate analysis datasets and TFLs from vendors.
• Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data.
• Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations.

Skills

SAS programming

CDISC data standards

FDA-regulated environment

Data management and validation

Education

BA/BS in computer science, statistics, math

MA/MS in relevant field

Tools

SAS

CDISC

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

• Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings;
• Produce data listings, summary tables, and graphics for interim and final analyses;
• Integrate data across studies within a project. Test, document, review, and validate all programs according to department guidelines;
• Coordinate data transfer and/or programming standards with CROs and vendors. Validate analysis datasets and TFLs from vendors;
• Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data;
• Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations.

Requirements:

• Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience;
• Expertise in SAS programming language, report generation, and standards for programming and validation;
• Therapeutic area- Rare Disease
• Experience With CDISC Data Standards Required.
• Experience as a senior statistical programmer at a pharmaceutical or CRO working in an FDA-regulated environment;
• Experience with Clinical Study Reports and NDA submission;
• Ability to work on multiple tasks simultaneously and meet project deadlines;
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.

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 are the core instruments 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 low 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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