Biostatistician II FSP (Early Phase)

Reposted 3 Days Ago
Be an Early Applicant
2 Locations
In-Office or Remote
Mid level
Software • Analytics • Biotech
The Role
Support early-phase (Phase I/IIa) clinical studies and biomarker analyses: contribute to study design, sample size calculations, analysis planning, statistical analyses, QC/review, reporting, and sponsor-facing communication.
Summary Generated by Built In
Who Are You? 

 
A Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support Early Phase clinical studies, in particular Phase IIa (Proof-of-Concept). You are excited and enthusiastic. 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 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: 

 
As a Biostatistician, you'll support activities related to early phase / Proof of Concept studies and Biomarker development. You will work closely with the sponsor's experienced Early Phase Biostatisticians and other stakeholders. 

 

 
Responsibilities

As a Biostatistician, your responsibilities will include:

 

  • Providing statistical support to early phase clinical studies (phase I and IIa)
  • Working with one or more experienced Biostatisticians, you will support different aspects of clinical trials processes (e.g. study design related contributions, analysis planning, reporting, QC, review of documentation) as required 
  • Performing statistical analyses using R, SAS or other tools as appropriate, and interpreting statistical results
  • Conducting exploratory analyses (e.g. Biomarker) as per the sponsor side's requests
  • Ensuring correctness and high quality of own deliverables
  • Effectively communicating with the sponsor side, including clarification of requirements, reporting progress, helping others understand the statistical approach used and interpret the results
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. is a plus.
  • Experience working in the Pharmaceutical or Biotechnology industry. 
  • Experience in sample size calculation, protocol concept development, protocol development, SAP desired.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is highly desirable.
  • Solid understanding & implementation of CDISC requirements for regulatory submissions.
  • The ability to communicate effectively both internally and externally.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.

Skills Required

  • Master's degree in statistics or a related discipline
  • Ph.D. in statistics or related discipline
  • Experience working in the Pharmaceutical or Biotechnology industry
  • Experience in sample size calculation
  • Experience in protocol concept development
  • Experience in protocol development
  • Experience with SAP (Statistical Analysis Plan)
  • SAS programming skills for QC of outputs and Efficacy/Safety tables
  • Knowledge of R programming
  • Solid understanding and implementation of CDISC requirements for regulatory submissions
  • Ability to communicate statistical methodology and results clearly to non-statistical stakeholders
  • Experience supporting early phase clinical studies and biomarker exploratory analyses

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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