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Puma Biotechnology, Inc. · 21 hours ago

Associate Director, Biostatistics - Remote Position

United States

Full-time

Remote

Lead/Staff, Director/Executive

$175K/yr - $205K/yr

8+ years exp

Puma Biotechnology, Inc. is seeking an Associate Director in Biostatistics to act as the independent Statistical lead for multiple drug projects. This role involves providing statistical input to clinical teams, ensuring adherence to regulatory guidelines, and supervising junior statisticians while maintaining quality deliverables.

BiotechnologyMedicalTherapeutics

Responsibilities

Provides Statistical input to clinical teams including design of studies and analyses requiring advanced statistical methodologies

Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, Statistical methods, data structures and presentation of results

Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses

Develops Statistical Analysis plan and statistical section of the protocol Ensures Statistical analyses performed in accordance with the protocol, Statistical analysis plan, good Statistical practice, and available regulatory guidelines

Provides topline reports of study results and is responsible for the data content of the clinical study report

Provides adequate vendor oversight of the study deliverables created.For example, ADAM/SDTM datasets and TFLs

Perform vendor qualification / audits in collaboration with functional management

Investigates new Statistical methodology and software and provides feedback to department

Resource planning and hiring

Mentors junior level Statisticians and CRO staff

Develops and maintains work instructions, guidelines and SOPs

Qualification

Ph.D. in StatisticsStatistical methodsOncology trials experienceStatistical softwareSAS programmingLeadership skillsCommunication skillsOrganizational skillsNegotiation skills

Required

Ph.D. in Statistics

Minimum of 8 year experience in applying Statistical methods in biomedical research, pharmaceutical or CRO for Oncology trials

Ability to visualize the big picture as the independent lead Statistician in a regulatory submission

Knowledge of international regulations (ICH, FDA, EMA)

Preferred

Advanced and broad knowledge of Statistical methods, along with understanding of industry practices related to the Statistical analysis of clinical data

Knowledge of Statistical software

In-depth familiarity with processes and procedures in data management and SAS programming