Associate Director, Biostatistics FSP

Posted Yesterday
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4 Locations
Remote
Senior level
Software • Analytics • Biotech
The Role
Lead and deliver statistical support for Phase II-III clinical trials embedded with a sponsor: design input, SAP/sample size, interim/final analyses, oversight of programmers/statisticians, regulatory submissions, and collaborate cross-functionally to ensure compliant, high-quality statistical deliverables. Apply advanced statistical methods and ML/DL for analytics and process automation.
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 Portfolio 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 team provides 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

As a AD Biostatistician, your responsibilities will include:

  • Lead statistical support for assigned clinical studies, taking ownership of key activities such as dry runs, interim analyses, DMC interactions, and final analysis and CSR delivery
  • Serve as the primary statistical contact for cross-functional teams, ensuring timely delivery and approval of high-quality, compliant statistical deliverables
  • Build and maintain strong collaboration with sponsor teams, acting independently while ensuring alignment with sponsor expectations and standards
  • Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
  • Provide statistical input into study design and key documents (protocol, CRFs, DMP, SAP), ensuring alignment with study objectives and sponsor expectations
  • Support development and review of analysis datasets and TLFs, working closely with programming teams to ensure quality and consistency of outputs
  • Contribute to clinical study reports and regulatory submissions, and support interactions with regulatory authorities as needed
  • Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery
  • Guide and oversee statisticians and programmers (as applicable) to ensure quality and consistency of statistical strategy, deliverables, and processes
     
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 clinical trial design, including adaptive designs, statistical methodologies, and data interpretation
  • Good understanding of the drug development process and cross-functional interfaces
  • 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
  • Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables
  • Experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
  • Ability to interact effectively with cross-functional stakeholders and external partners
  • Strong focus on timely, high-quality and compliant deliverables with clear accountability for outcome
  • Ability to proactively identify risks and ensure appropriate mitigation and follow-up
  • Effective communication skills (clear, concise, and professional)
  • Strong organizational and project management skills
  • Collaborative, flexible, and solution-oriented mindset
  • High attention to detail and quality
     

Skills Required

  • Master's degree in Statistics or related quantitative discipline
  • PhD in Statistics or related quantitative discipline
  • ~7+ years experience supporting clinical trials in the pharmaceutical/biotech industry
  • ≥3 years recent experience in Phase II-III studies, including SAP development, sample size calculation, and TLF review
  • Strong knowledge of clinical trial design, including adaptive designs, statistical methodologies, and data interpretation
  • 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
  • Experience supporting end-to-end trial delivery (protocol input through CSR contributions)
  • Ability to lead, guide, and oversee statisticians and programmers and serve as primary statistical contact
  • Experience employing statistical methods, machine learning and deep learning algorithms for data analysis and automation
  • Strong organizational and project management skills, with accountability for timely, high-quality deliverables
  • Effective communication skills and ability to interact with cross-functional stakeholders and external partners
  • High attention to detail, quality, and proactive risk identification/mitigation

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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