Senior Biostatistician FSP

JOB DESCRIPTION

Who Are You?

An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods. You will have experience supporting or leading one or more Phase I-IV clinical studies. You are excited and enthusiastic, motivating your teams to do great work and collaborating easily with your clients. You never settle for what is, but always push clinical development forward to what it could be, motivating 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 HTA submissions to country-specific authorities or to internal customers within the client organization. Experience with HTA work is a bonus, as is experience in late-stage trials in oncology and familiarity with survival analysis methods. Experience with analyzing PRO data is also a bonus, for example, understanding the scoring methods for questionnaires and implementation of country-specific utility scoring algorithms.

RESPONSIBILITIES

As a Senior Biostatistician, your responsibilities will include:

1. Providing statistical support to HTA analyses based on clinical trial data.
2. Participating in the development of analysis plans to address HTA customer requests.
3. Developing or reviewing statistical analysis plans (SAPs), including analysis dataset and output specifications.
4. Performing statistical analyses and interpreting statistical results.
5. Working with statistical programming to create the required outputs, including checking that the outputs created meet specified requirements and standards.
6. Preparing HTA reports for efficacy, safety, and patient-reported outcomes (PRO), following the client's standards and templates for such reports.
7. Utilizing strong communication skills to understand work requirements, work effectively and independently in the client team to meet analysis requirements, and communicate with the project team lead and other functions in a timely manner to meet delivery requirements.
8. Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
9. Collaborating with internal and external functions to ensure meeting project timelines and goals.

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:

1. Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
2. 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
3. Experience working for a CRO is strongly desired.
4. Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
5. Good SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers. Knowledge of R programming is a plus.
6. Solid understanding & implementation of CDISC requirements.
7. Adept in ADaM specifications generation and QC of datasets.
8. The ability to build strong external & internal relationships and motivate a regional or global team.
9. Effective communicator: able to explain methodology and consequences of decisions in lay terms.