Lead Biostatistician – Oncology Clinical Studies

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the statistical design and analytical planning for oncology clinical utility studies.

• Offer technical expertise in sophisticated study design methodologies and data analysis.

• Suggest and validate efficient study designs for intricate oncology scenarios.

• Act as the study statistician for various studies.

• Collaborate with clinical, medical, and translational partners throughout the study planning, development, and implementation phases.

• Recognize potential risks, articulate concerns, and advocate for solutions to interdisciplinary teams and executive leaders.

• Write and review statistical analysis plans, statistical reports, TLFs, CSRs, and publications.

• Propose and implement innovative statistical methods.

• Mentor junior statisticians in their career development.

• Assist in the ongoing enhancement of departmental processes, tools, and templates.

• Collaborate on the creation of publication manuscripts.

⛳️ Requirements

• Advanced degree in Biostatistics, Statistics, or a related quantitative discipline (Ph.D. preferred).

• A minimum of 4 years of experience in biostatistics related to clinical trials.

• Strong knowledge in time-to-event analysis, including the management of censoring, competing risks, and advanced survival modeling techniques typically used in oncology.

• Expertise in innovative study design, encompassing adaptive designs and biomarker-informed approaches, power calculations, and endpoint assessments.

• Familiarity with ICH and GCP guidelines and CDISC standards, including SDTM and ADaM.

• Proficient in R programming.

• Exceptional capability to independently design clinical studies.

• Experience with biomarker-enabled clinical study designs, sample size determination, and endpoint evaluation.

• Capacity to thrive in fast-paced, cross-functional environments with collaborators from varied technical backgrounds.

• Ability to convey complex statistical concepts effectively to both technical and non-technical audiences.

• Familiarity with NGS-based diagnostics and ctDNA/MRD is preferred.

• Experience with non-inferiority studies is preferred.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans available for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits offered.

• Leave for pregnancy and baby bonding.

• 401(k) benefits.

• Commuter benefits.

• Employee referral program.

• Commitment to being an Equal Opportunity Employer and fostering a diverse, inclusive workplace.