Principal Biostatistician FSP - RWE - Remote

Posted Yesterday
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3 Locations
In-Office or Remote
Senior level
Software • Analytics • Biotech
The Role
Lead post-submission and RWE evidence generation using CDISC, claims, and biological data. Create SAP, contribute to CRF/protocol, produce high-quality statistical programming, consult with clinical scientists, manage stakeholder expectations, and identify analysis limitations.
Summary Generated by Built In

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. 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.

We are seeking a Senior/Principal level biostatistician to fill a post-submission and RWE role with a major client. This individual should be an experienced/veteran statistician in the healthcare industry and looking to take on a leadership role in such an environment. 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.

#LI-KO1
#CYTELINT


Skills Required

  • At least 5 years industry experience for PhD-level candidates or 8 years for Master's-level candidates
  • 3-5 years experience in a regulated/industry environment (CRO, Pharma, regulatory body, or health services)
  • Extensive experience in evidence generation using RWE data (claims, EHR, or other types)
  • Programming skills with SAS, R, and SQL (strong knowledge in either R or SAS)
  • Strong mathematical statistics background to understand novel methods
  • Creation of SAP and participation in CRF and protocol development
  • Produce high-quality, well-documented statistical programming, analyses, outputs, and reports
  • Good oral and written English communication skills
  • Ability to work independently and collaboratively; confident, self-reliant, quick learner
  • Extensive experience leading post-submission evidence generation using CDISC datasets and claims data
  • Experience with SQL queries and cloud-based databases (e.g., Snowflake, Databricks)
  • Experience with rare diseases or neurological diseases

Cytel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.

  • Healthcare Strength Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
  • Retirement Support A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
  • Fair & Transparent Compensation Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.

Cytel Insights

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The Company
HQ: Cambridge, MA
1,395 Employees
Year Founded: 1987

What We Do

Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com

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