Lead Oncology Biostatistician (Remote)

Sumitomo Pharma; Honolulu (HI); A distancia; USD 128.000 - 159.000; Jornada completa

Descripción de la vacante

Sumitomo Pharma America (SMPA) seeks a Biostatistics Manager (Oncology) to lead statistical activities across oncology trials, shaping study design and analysis plans. You will author SAPs, review TLFS, and collaborate with programming and data management teams to ensure rigorous, regulator-ready deliverables.

The role requires strong statistical expertise, FDA/EMA knowledge, and the ability to mentor junior staff in a fast-paced, remote environment with periodic on-site meetings.

Formación

• MS and 4 yrs of experience in Statistics, Biostatistics, or a related quantitative discipline or PhD in Statistics, Biostatistics, or a related quantitative discipline.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH, and other applicable regulatory guidelines.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Experience supporting the design, analysis, and reporting of clinical trials.
• Proficiency in SAS programming; experience with R is desirable.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Experience contributing to protocols, SAPs, CSRs, and regulatory submission documents.
• Oncology clinical development experience is preferred.
• Experience working with CROs and external vendors is desirable.

Responsabilidades

• Serve as lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoint selection, sample size determination, randomization methodology, and analysis strategy.
• Contribute to the development and review of clinical study protocols.
• Author and review Statistical Analysis Plans (SAPs).
• Collaborate with Statistical Programming in the development and review of analysis datasets, tables, listings, and figures (TLFs).
• Review statistical outputs and ensure the quality, consistency, and accuracy of study deliverables.
• Interpret study results and communicate findings to multidisciplinary project teams.
• Contribute to the preparation of Clinical Study Reports (CSRs), abstracts, publications, and regulatory documents.
• Support regulatory submissions and responses to health authorities.
• Collaborate with CRO statisticians and programming teams to ensure timely and high-quality deliverables.
• Ensure compliance with regulatory requirements, company procedures, and industry standards.
• Participate in departmental initiatives to improve statistical processes and standards.
• Provide technical guidance and mentoring to junior statisticians as needed.

Conocimientos

Statistical analysis

SAS programming

Cross-functional collaboration

Communication

Mentoring junior statisticians

Educación

MS or PhD in Statistics/Biostatistics

Herramientas

R

CDISC SDTM/ADaM

Descripción del empleo

Sumitomo Pharma America (SMPA) seeks a Biostatistics Manager (Oncology) to lead statistical activities across oncology trials, shaping study design and analysis plans. You will author SAPs, review TLFS, and collaborate with programming and data management teams to ensure rigorous, regulator-ready deliverables.

The role requires strong statistical expertise, FDA/EMA knowledge, and the ability to mentor junior staff in a fast-paced, remote environment with periodic on-site meetings.