ClinChoice - Senior Statistical Programmer/Analyst Consultant (TA -Gene Therapy)-Remote

United States1w ago

In Office Senior NA Medical Devices Pharmaceuticals Programmer QA Analyst Clinical Trials Reporting SAS CRO Close Quality Control

Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. • Hands-on experience supporting Gene Therapy clinical trials is required. • Strong proficiency in SAS programming. • Strong knowledge of CDISC standards, including SDTM and ADaM. • Experience developing and validating clinical trial TLFs. • Ability to independently lead study-level programming activities. • Understanding of clinical trial processes, statistical analysis, and regulatory reporting. • Excellent analytical, communication, and problem-solving skills. • 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? • 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 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.

Responsibilities

• Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting. • Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs). • Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications. • Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses. • Support interim and final analyses, database lock activities, and Clinical Study Report preparation. • Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements. • Perform independent validation and quality control of datasets, TLFs, and other programming outputs. • Support regulatory submissions and address programming-related questions from internal and external stakeholders. • Manage study-level programming timelines, deliverables, and quality expectations. • Identify and resolve complex programming issues and proactively communicate risks. • Provide technical guidance and mentorship to other Statistical Programmers. • Participate in client-facing meetings and collaborate with cross-functional project teams.