Senior Biostatistician - Madrid - Catalyst Clinical Research

Descripción

Catalyst Clinical Research

A continuación se detalla todo lo que necesita saber sobre lo que implica esta oportunidad, así como lo que se espera de los solicitantes.

provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services.

The company's customer‑centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies.

Position
Senior Biostatistician

A key member of the Oncology Operations, Biostatistics Team, the Senior Biostatistician serves as the primary statistical representative for biometrics standalone projects or otherwise complex studies.

The role effectively manages broad‑based projects such as NDA submissions or complex, multi‑protocol programs, coordinating activities across multiple locations.

The individual develops and reviews statistical analysis plans based on study‑specific documents and sound statistical methodology, assists in developing and maintaining ADaM specifications, and provides senior oversight to junior level biostatistics staff.

Position Responsibilities

Lead low to high complexity studies across various phases of development and provide senior oversight on low or moderate complexity studies.

Effectively manage broad‑based projects such as NDA submissions or complex, multi‑protocol programs, coordinating activities across multiple projects simultaneously.

Collaborate with internal and external project team personnel to meet project deliverables and timelines for statistical data analysis and reporting.

Identify project priorities and communicate associated timelines to departmental management.

Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies.

Represent the department and company in multi‑disciplinary settings, including project team meetings, client meetings / presentations, and bid defense meetings.

Provide statistical advice regarding clinical study design, endpoints, sample size requirements, and document review / approval.

Develop and review statistical analysis plans based on study‑specific documents and sound statistical methodology.

Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures.

Ensure the quality and integrity of data analysis and reporting by programming checks using SAS.

Monitor project budgets and support project forecasting efforts.

Contribute to departmental objectives and strategies.

Position Qualifications

Master's degree, equivalent, or higher in biostatistics or a related field.

A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.

Minimum of 5+ years of relevant work experience.

Previous experience in pharmaceutical research or CRO setting required.

Prior experience in multiple therapeutic areas required, with experience in Oncology preferred.

Required Skills

Knowledge of clinical trial study design and multiple therapeutic areas.

Able to work independently on multiple, concurrent projects.

Lead study team meetings as needed.

Capable of conducting exploratory statistical analyses using statistical software packages.

Proficient with Microsoft Office Suite.

Excellent written and oral communication skills.

Strong organizational, problem‑solving, and analytical skills.

Ability to manage priorities and workflow.

Versatility, flexibility, and a willingness to work within constantly changing priorities.

Proven ability to handle multiple projects and meet deadlines.

Ability to deal effectively with a diversity of individuals at all organizational levels.

Commitment to excellence and high standards.

Creative, flexible, and innovative team player.

Good judgement with the ability to make timely and sound decisions. xugodme

Ability to travel for meetings or training activities.

Ability to program simple checks for ADaM or TLF review using SAS and / or R.

Additional Details


Seniority Level:
Mid‑Senior Level


Employment Type:
Full‑time


Job Function:
Research, Analyst, and Information Technology


Industries:
Research Services

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