{bc}
Apply
oracle

Associate Director, Biostatistics FSP

Cytel
Remote, USA
Full-time
Director · 7+ years experience
Remote
Discovered 4 days ago
sapsas

Full Job Posting

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

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

Preferred Qualifications

  • Master’s degree in Statistics or related quantitative discipline; PhD preferred
  • Prior experience on Hematology studies preferred

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Cytel

Vice President, FSP Operations

, IND

Discovered 2 days agoFull-time

Associate Director, Biostatistics FSP

, USA

Discovered 4 days agoFull-time

Clinical R Automation & AI Solutions Developer FSP

, IND

Discovered 5 days agoFull-time

Senior IT Infrastructure Engineer

, USA

Discovered 5 days agoFull-time

Principal Biostatistician FSP - Translational Medicine

, IND

Discovered 5 days agoFull-time

Senior Research Consultant, Evidence Review and Software

, GBR

Discovered 6 days agoFull-time

Director, Biostatistics FSP

, USA

Discovered 1 weeks agoFull-time