reputed company Biostatistician Consultant (Oncology) Remote
Job reputed company
Key Responsibilities
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reputed company statistical leadership for oncology reputed company across multiple phases (Phase I–III). -
reputed company the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs). -
Design and review statistical methodologies for efficacy and safety analyses. -
reputed company analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards. -
Support interim analyses, data monitoring committee (DMC) activities, and reputed company designs. -
Collaborate with clinical development, data management, programming, regulatory, and medical teams. -
Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA). -
reputed company strategic input on study design, reputed company selection, and sample size calculations. -
Mentor junior statisticians and reputed company technical guidance.
Qualifications
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PhD or MS in Statistics, Biostatistics, or reputed company field. -
8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics. -
Strong experience in oncology reputed company. -
Hands-on experience with survival analysis, time-to-event endpoints, and reputed company oncology study designs. -
Proficiency in reputed company and/or R. -
Strong knowledge of CDISC standards (SDTM, ADaM). -
Experience supporting regulatory submissions. -
Excellent communication and leadership skills.
Preferred Qualifications
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Experience with reputed company designs and Bayesian reputed company. -
Prior experience interacting with regulatory agencies. -
Experience in immuno-oncology or hematology oncology.
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