Associate Director, Biostatistics FSP

Posted Yesterday
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2 Locations
Remote
Senior level
Software • Analytics • Biotech
The Role
Lead statistical activities for Phase II–III clinical trials from protocol design through reporting. Responsibilities include SAP development, sample size calculations, statistical analysis, TLF review, database lock and submission support, regulatory responses, vendor oversight, and cross-functional collaboration. Use SAS and/or R for analyses, modeling, simulation, exploratory work, and quality control. Coordinate statistical activities across studies and apply adaptive, group sequential, count-data, machine learning, and deep learning methods.
Summary Generated by Built In
Who Are You? 
As an Associate Director of Biostatistics, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience and utilize advanced statistical methods in their Global Therapeutic Statistics group.   

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: 
Our Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
 
Responsibilities

Your responsibilities will include:

  • Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
  • Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
  • Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
  • Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
  • Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
  • Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc. 
  • Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery
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 related quantitative discipline; PhD preferred
  • 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry
  • Solid recent experience (≥3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review
  • Strong knowledge of adaptive design, group sequential and statistical methods of count data
  • Prior experience on Hematology studies preferred
  • Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
  • Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions
  • Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
  • Excellent and effective communication skills (clear, concise, and professional) and ability to interact effectively with cross-functional stakeholders and external partners
  • Strong organizational and project management skills
  • Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables

Skills Required

  • Master's degree in Statistics or a related quantitative discipline
  • PhD in Statistics or a related quantitative discipline
  • 7+ years of experience supporting clinical trials in the pharmaceutical or biotechnology industry
  • At least 3 years of recent experience in Phase II–III studies
  • Experience with SAP development, sample size calculation, and TLF review
  • Strong knowledge of adaptive design, group sequential methods, and statistical methods for count data
  • Prior experience in Hematology studies
  • Understanding of the drug development process and cross-functional interfaces
  • Experience supporting end-to-end clinical trial delivery from protocol input through CSR contributions
  • Working knowledge of EMA, FDA, and ICH guidelines and regulatory expectations
  • Proficiency in SAS and/or R
  • Excellent communication and cross-functional stakeholder interaction skills
  • Strong organizational and project management skills
  • Ability to work independently, take ownership, and remain accountable for study-level statistical activities and deliverables

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.

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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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