Senior Biostatistician FSP

Cytel; Colombia; On-site; COP 120,000,000 - 220,000,000; Full time

Job summary

Cytel seeks an experienced Senior Biostatistician to support or lead Phase I–IV clinical studies within a sponsor-embedded role. You will perform statistical analyses, help design studies, and collaborate with CROs and client teams to drive regulatory submissions.

The ideal candidate holds a Master’s in statistics (PhD preferred) with 5+ years in pharma/biotech, SAS and R expertise, and a strong grasp of CDISC/ADaM standards.

Qualifications

• Master’s degree in statistics or a related discipline; PhD strongly desired.
• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Experience with oncology is a bonus.
• Solid understanding & implementation of CDISC requirements for regulatory submissions.
• Good SAS programming skills for QCing outputs; knowledge of R is a plus.

Responsibilities

• Providing statistical support to clinical studies.
• Participating in study design discussions and sample size calculations.
• Reviewing CRFs and developing SAPs, datasets, and specifications.
• Performing statistical analyses and interpreting results.
• Preparing clinical study reports and integrated summaries for submissions.
• Communicating methodology and implications of decisions clearly.
• Ensuring compliance with FDA regulations, GCP, and eSubmission guidelines.
• Contributing to standards for programming tools, outputs, and macros.
• Collaborating with CROs, vendors, and partners to meet timelines.

Skills

Statistical analysis

Communication skills

Regulatory submissions

Study design

Team leadership

Education

Master’s degree in statistics

PhD preferred

Tools

SAS

R

CDISC

ADaM

Job description

Who Are You?

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Job Description

Who Are You?

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview

Our Senior Biostatisticians perform statistical analyses to support clinical trial/marketed product submissions to regulatory agencies. Having exposure to oncology is a bonus.

Responsibilities

As a Senior Biostatistician, your responsibilities will include:

• Providing statistical support to clinical studies
• Participating in the development of study protocols, including participation in study design discussions and 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 statistical results
• Preparing clinical study reports, including integrated summaries for submissions
• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Experience working for a CRO is strongly desired.
• Experience with oncology is a bonus.
• Experience 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 & implementation of CDISC requirements for regulatory submissions.
• Adept in ADaM specifications generation and QC of datasets.
• The ability to build strong external & internal relationships and motivate a regional or global team.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.