Remote Associate Director, Biostatistics & Clinical

Sumitomo Pharma

Salt Lake City (UT)

À distance

USD 166 000 - 207 000

Plein temps

Il y a 6 jours
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Résumé du poste

Sumitomo Pharma is actively seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will collaborate with cross‑functional teams to design studies, guide analyses, and support regulatory submissions.

The role requires a PhD or MS with extensive pharma experience, expertise in SAS/R, and a track record in oncology/hematology programs. Remote US work is available with domestic/international travel as needed.

Qualifications

  • PhD in Statistics, Biostatistics, or related field with at least 5 years in pharma/biotech.
  • MS with at least 8 years of relevant pharma/biotech experience.
  • Experience providing statistical leadership for clinical programs and trials.
  • Experience supporting regulatory interactions and submissions.
  • Oncology or hematology background preferred.
  • Experience overseeing CROs, vendors, or external partners.

Responsabilités

  • Serve as biostatistics lead for one or more clinical programs and provide strategic input into plans and analyses.
  • Represent Biostatistics on cross-functional teams and integrate statistics into key decisions.
  • Lead regulatory interactions, including briefing documents and regulatory questions.
  • Author or oversee statistics sections of protocols, SAPs, submissions, and publications.
  • Provide statistical interpretation and support data-driven program decisions.
  • Identify risks and mitigation strategies; oversee CRO/statistical vendor activities.

Connaissances

Statistical leadership
SAS
R
Regulatory insight
Communication
Cross-functional
Bayesian methods
Trial design

Formation

PhD in Statistics/Biostatistics
MS in Statistics/Biostatistics

Outils

SAS
R

Description du poste

Sumitomo Pharma is actively seeking an Associate Director, Biostatistics to lead statistical strategy across clinical development programs. You will collaborate with cross‑functional teams to design studies, guide analyses, and support regulatory submissions.

The role requires a PhD or MS with extensive pharma experience, expertise in SAS/R, and a track record in oncology/hematology programs. Remote US work is available with domestic/international travel as needed.

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