Senior/Principal Biostatistician FSP - Madrid - Cytel

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Senior/Principal Biostatistician FSP

role at

Cytel

A Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support Phase I–IV clinical studies.

You are excited, enthusiastic, motivate teams, collaborate easily with clients and push clinical development forward.

Job Description

Working fully embedded within one of our pharmaceutical clients, you will be dedicated to advancing the next generation of patient treatment, working with autonomy and ownership.

You will perform ad‑hoc or exploratory analyses to support submissions or Health Authority questions, translating regulatory questions into statistical problems and collaborating with clinical and regulatory colleagues.

Responsibilities

Providing statistical support to clinical studies.

Participating in the development of study protocols, including sample size calculations.

Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.

Performing statistical analyses and interpreting results.

Preparing clinical study reports, including integrated summaries for submissions.

Utilizing strong communication skills to present and explain methodology and consequences of decisions.

Qualifications

Master's degree in statistics or a related discipline; Ph.
D. strongly desired.

3+ years supporting clinical trials in the pharmaceutical or biotechnology industry.

Experience working for a CRO is strongly desired.

Expertise in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.

Good SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers; knowledge of R programming is a plus.

Solid understanding and implementation of CDISC requirements for regulatory submissions.

Adept in ADaM specifications generation and QC of datasets.

Ability to build strong external and internal relationships and motivate a regional or global team. xugodme

Effective communicator:
able to explain methodology and consequences of decisions in lay terms.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing

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