Principal Biostatistician FSP - RWE

JOB DESCRIPTION

Cytel is a place where talent, experience and integrity come together to advance the state of drug development. In this role you will join our FSP department and will for our client, one of the top pharmaceutical companies.

The expectation is this person will be able to bring mature computational, operational and production experience to lead post submission evidence generation using CDISC datasets, Claims, and raw biological data.

RESPONSIBILITIES

You will contribute by:

• Understand, interpret, and integrate data from various sources to ensure clinical/biological/regulatory questions can be answered appropriately with the available data.
• Creation of SAP, participate in creation of CRF, and protocol development.
• Creation statistical programming of high quality and well documented data manipulation, analysis, outputs, and reports.
• Identify, communicate and be strongly vocal about potential issues and limitations in statistical analysis and result interpretation to stake holders.
• Provide statistical consultation to clinician scientist to frame biological questions into statistical hypothesis and explore raw biological data.
• Plan, understand, manage expectations of stake holders in terms of project resourcing, feasibility, deliverables, and timeline.

Recommended:

• Extensive experience leading post-submission evidence generation using CDISC data and Claims data (e.g., for HEOR Market Access of various country, Reimbursement)
• Experience with SQL queries and cloud-based databases (e.g. Snowflake and Databricks).
• Extensive work experience with rare diseases or neurological diseases.

What’s in it for you:

• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
• Work with and leverage the best and brightest minds in the industry

QUALIFICATIONS

What we’re looking for:

• At least 5 years of experience, preferably in the pharmaceutical industry, biotechnology, or consulting environment for Doctoral-level candidates (PhD/DSc/DrPH), or 8 years of industry experience for Master’s-level candidates (MPH, MSPH/ MSc)
• 3-5 years of experience in a regulated/industry environment (e.g., CRO, Pharmaceutical Company, Governmental regulatory body, health services provider.)
• You have extensive experience in evidence generation using a RWE data (claims, EHR, or other types).
• You have good programming skills with SAS, R, SQL and strong knowledge either R or SAS.
• You have a strong mathematical statistics background to understand novel methods presented at conferences.
• You can work independently and in a team.
• You are confident, self-reliant, and a quick learner.
• Good oral and written English communication skills are mandatory.

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