Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US

Description

You work directly for one sponsor on a client engagement, with the security and added career options of a global full-service CRO.

The company is recruiting a senior statistical programmer consultant to join one of its clients.

The company runs over 4,000 staff in more than 20 countries across the Americas, Europe and Asia-Pacific, and has delivered for 28 years.

This is a client-facing role. You work on your own while building high-trust working relationships with the client's team.

You will lead statistical programming for clinical trials, with strong SAS and CDISC skills, and work with statisticians, clinical teams and other stakeholders.

Responsibilities

• Own statistical programming for oncology studies, from study start-up through database lock, analysis and reporting.
• Build and maintain high-quality SAS programs for SDTM, ADaM and TLFs.
• Lead programming for interim and final analyses, including complex efficacy and safety work.
• Work with biostatisticians to turn statistical analysis plans and study requirements into programming specifications.
• Review programming specifications against protocols, SAPs and statistical methods.
• Help create and validate CDISC-compliant SDTM and ADaM datasets.
• Produce and validate TLFs for clinical study reports, regulatory submissions and other deliverables.
• Carry out independent programming validation and quality control of outputs and datasets.
• Support submission work and answer programming and data questions from cross-functional and regulatory teams.
• Spot programming risks early and tell stakeholders about risks, timelines and solutions.
• Coordinate work across studies so deliverables meet agreed timelines and quality standards.
• Guide and mentor statistical programmers and other programming team members.
• Join client and project meetings and explain technical points clearly to technical and non-technical audiences.

Requirements

• Required: a bachelor's or master's degree in statistics, biostatistics, mathematics, computer science or a related field.
• Required: solid experience in clinical trial statistical programming.
• Preferably: that experience gained at a CRO, pharmaceutical or biotechnology company.
• Required: significant experience on oncology clinical trials.
• Required: experience supporting regulatory submissions.
• Required: strong SAS proficiency, including Base SAS and the procedures used in clinical trial reporting.
• Required: strong knowledge of CDISC standards, particularly SDTM and ADaM.
• Required: experience developing and validating TLFs for clinical trials.
• Required: experience with complex clinical trial data and supporting statistical analyses.
• Required: ability to manage programming deliverables independently and lead study-level programming.
• Required: a clear understanding of clinical development, including protocols, SAPs, datasets, TLFs and clinical study reports.
• Required: strong communication, organisation, problem-solving and collaboration skills.
• Preferred: basic or working knowledge of R programming.

Conditions

This is a senior-level contract role.

The role is remote and open to candidates in the US.

Equal opportunity: the company hires and promotes without regard to gender, race, belief or ethnicity.

Benefits

• Career opportunities that come with working for a global CRO, alongside the security of that employer.
• Continuous training to keep your skills and expertise current, with clear tools for managing client and internal processes.