Biostatistician

See Yourself at Telix

We are seeking an experienced biostatistician as part of our Clinical Strategy and Innovation team to support the rational design, execution and associated data collection and analysis of clinical studies across the product portfolio.

The biostatistician will provide biostatistical support to the preparation of clinical protocols, regulatory submissions, conference abstracts and presentations, manuscripts for potential publication and other medical and scientific materials. They will act as the Telix statistical representative at global regulatory meetings.

Key Accountabilities:

• Provide strategic statistical input to the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, ethics committees and institutional review boards and other authorities and agencies. More specifically:
• Provides statistical leadership and expertise in support of the clinical development activities and ensure effective, timely, and high-quality delivery of project goals.
• Plans, directs and organizes statistical activities including study protocol development, statistical method, data analysis and interpretation, and make sure clinical trials are well designed, properly analyzed and clearly presented to support new compound development, regulatory submissions and the maintenance and growth of existing products.
• Works collaboratively with internal and external (CRO) team members to coordinate the planning and execution of statistical deliverables
• Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Designs and specify stratification /randomization schema; reviews and approve test randomization lists
• Lead Data Management, Clinical Development and Clinical Operations on design and review of eCRFs, and ensure data collection meet the requirements of statistical analyses
• Author or oversee the development of statistical analysis plans for clinical trials, provide guidance to statistical programmers on SDTM/ADaM and oversee the development of shells for tables, figures and listings
• Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents.
• Establish and maintain collaborative relationships across functions internal to Telix and act as subject matter expert for internal and external consultation. Participate in internal and external committees as appropriate.
• Effectively interact with members in other functions including medical, regulatory, safety, clinical operation, and translational medicine for strategic planning to ensure optimized clinical development in accordance with corporate objective
• Drive the development, implementation and growth of the biostatistics function within the organization with the objective of building an integrated cost-center and function.
• Review and analyze safety reporting data, biomarker analyses and other routine and novel aspects of clinical trial reporting.
• Plan and execute computer data file structures and develop, manage, and maintain statistical databases. Oversee, or perform, when necessary, data entry, management and analysis.
• Evaluate statistical software packages, lead statistical programming and data entry teams where relevant.
• Provide biostatistical oversight of contract research organizations and provide support to clinical trial sites when required.
• Represent the company in interactions with industry and academic partners, regulatory authorities, clinical research organization and other vendors as appropriate – e.g., FDA meetings, bid defense meetings.
• Maintain knowledge to enable ongoing execution of function as biostatistics expert. Maintain working knowledge of the Telix clinical development pipeline.

Education and Experience:

• Bachelor of Science with specialization in statistics, or Bachelor of Mathematics and statistics or other relevant qualification required
• Advanced degree specializing in statistical methods desirable
• 7+ years of experience in biostatistics supporting clinical drug development in the pharmaceutical industry required
• Experience in oncology/radiopharmaceutical drug development desirable but not essential
• Strong working knowledge of advanced statistical software packages

Key Capabilities:

• Demonstrated ability to function in a collaborative, cross-functional matrix environment to develop clinical assets.
• Ability to apply advanced statistical techniques in support of scientific research studies and clinical trials.
• Skilled in Machine Mining techniques like Logistic Regression, Decision Trees, Principal Component Analysis, Clustering and Segmentation, Artificial Neural Networks.
• Good at Hypothesis Testing, F-test, T-test, ANOVA, Regression Analysis, Time Series Analysis, Survival Analysis, Bayesian Analysis, Multivariate Analysis, Categorical Data Analysis, Longitudinal Data Analysis, Generalized Linear Model, Markov chain Monte Marlo Algorithm, Model/Variable Selection Techniques, Step Wise Selection, Ridge Regression, Lasso, SCAD, Cox Proportional Hazard Model, Mixed-effects Model
• Ability to consult with clinical investigators, interpret research requirements and determine statistical analysis strategies.
• Ability to plan and drive execution of multiple projects under tight timelines.
• Ability to provide technical guidance and leadership to professional personnel in area of expertise.
• Knowledge of data management and regulatory requirements for clinical trials and drug development.
• Knowledge of scientific and medical reporting and manuscript preparation requirements and standards
• Strong organizational and interpersonal communication, writing and presentation skills.
• Ability to think and execute strategically in the context of clinical asset development.
• Ability to prioritize deliverables and manage time effectively.