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

Description

The role is a contract position working directly for a single sponsor, with support from a global CRO that offers job security and wider career options.

The company is a global full-service CRO with over 4,000 staff across more than 20 countries and 28 years of delivery. It works across pharmaceutical, biotechnology, medical device and consumer health clients.

You will lead statistical programming on a Gene Therapy study, working with Biostatisticians and cross-functional teams. The work requires strong SAS skills, solid knowledge of clinical trial data and regulatory rules, and the ability to own programming deliverables.

Gene Therapy clinical development experience is essential. Oncology or Internal Medicine experience is a plus.

The role is client-facing and independent, so you need confidence and the ability to build trust with the client's team.

Responsibilities

• Lead programming for Gene Therapy trials from start-up through database lock, analysis and reporting.
• Build, review and validate SAS programs for SDTM, ADaM, tables, listings and figures.
• Work with Biostatisticians on protocols, SAPs and programming specifications.
• Produce and validate clinical datasets and statistical outputs for safety and efficacy.
• Support interim and final analyses, database lock and Clinical Study Report preparation.
• Make sure deliverables meet CDISC standards and relevant regulations.
• Run independent QC on datasets, TLFs and other outputs.
• Support regulatory submissions and answer programming questions from internal and external stakeholders.
• Own study-level programming timelines, deliverables and quality.
• Solve complex programming problems and flag risks early.
• Guide and mentor other Statistical Programmers.
• Attend client meetings and work with cross-functional project teams.

Requirements

• A Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science or a related field.
• Significant clinical trial statistical programming experience in pharma, biotech or a CRO.
• Hands-on experience on Gene Therapy clinical trials is required.
• Strong SAS programming skills.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience building and validating clinical trial TLFs.
• Ability to lead study-level programming without close supervision.
• Understanding of clinical trial processes, statistical analysis and regulatory reporting.
• Strong analytical, communication and problem-solving skills.

Conditions

Contract role, fully remote.

Applications go through a CV review, and shortlisted candidates are invited to a phone interview. Only shortlisted candidates receive a reply.

The company is an equal opportunity employer that values diversity in gender, race, beliefs and ethnicity.

Benefits

• Direct work with a single sponsor, plus the security and career paths of a large CRO.
• Continuous training and close management, with turnover below the industry average.