Principal Biostatistician - Oncology Clinical Trials

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

This position is responsible for performing activities related to biostatistics function in support of clinical trials while maintaining a high level of quality and integrity of data analysis. This position reports to the Head of Biostatistics.

Essential Functions:

• Key point of contact for the sponsor and the study team on all clinical trial biostatistics activities.

• Contribute to trial planning as a statistical consultant and advisor to Sponsors in the areas of study design and sample size calculations.

• Write and/or review Statistical Considerations sections for clinical trial protocols.

• Independently develop statistical analysis plans (SAPs), including the definition of derived data sets and the design of templates for statistical tables, figures, data listings and/or graphs for clinical summary reports. Review/edit SAPs created by other team members.

• Perform statistical analyses and interpret results of these analyses.

• Oversee statistical analyses performed by junior biostatisticians and statistical programmers and interpret results of these analyses.

• Prepare statistical summary reports.

• Write the statistical methods sections and write and/or review statistical results sections of draft integrated study reports, including PK and/or PD analysis as applicable.

• Review and approve draft integrated study reports.

• Ensure that analysis and programming work is documented and archived in a complete audit trail.

• Create and maintain biostatistics files for each assigned project and ensure inclusion of required documents in the Trial Master File.

• Work directly with study/project teams to identify statistical issues and propose and implement solutions.

• Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed.

• Research and apply new statistical approaches as needed. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.

• Represent TD2 during Sponsor meetings, bid defense meetings, Data Safety Monitoring Boards (DSMBs), and quality audits related to biostatistics activities at TD2.

• Provide quality control activities by reviewing and providing feedback on the work of others.

• Perform other related duties as assigned.

Job Requirements:

• Master’s degree in Biostatistics/Statistics is required, with Ph.D. degree preferred. Equivalent work experience may be substituted for education at TD2’s discretion

• Minimum 8 years of relevant experience in the biopharmaceutical industry.

• Experience in early phase oncology trials preferred. Experience with adaptive clinical trial designs is a plus. Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac or AME trials may be substituted at TD2’s discretion.

• Hands-on experience in all tasks of a Study Statistician (at least 6 years) or Lead Statistician (at least 2 years). Experience with regulatory submissions, registries, or Health Authority interactions is a plus.

Required Specialized/Technical Skills:

• Understanding of all Phases oncology clinical trials.

• Vendor oversight experience.

• Knowledge of the drug development process, from early to late stage.

• Understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions.

• Experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations.

• Proficiency in SAS programming to perform statistical analyses and produce ad hoc tables, listings and figures. Experience with other statistical software such as R a plus.

• Experience with data pooling to support Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) and periodic reports is preferred.

• Understand and use relevant computer languages and software packages. Write programs to select, retrieve, manipulate, edit, and analyze data.

• Trained in Good Clinical Practices (GCP).

• Experience with successfully transitioning into clinical trial biostatistics work mid-study is preferred.

• Ability to manage multiple tasks with competing timelines.

• Excellent communication and interpersonal skills. Ability to explain statistical concepts to non-statisticians.

• Client focused approach to work.

• Ability to train and lead the work of others.

• Solution oriented, attention to detail, interest and ability to perform in a high-demand and dynamic working environment.

• Skills using other computer programs used in business, such as Microsoft Excel and Word, is preferred.

• Possess strategic thinking, contingency planning, problem-solving and dispute resolution skills.

• Ability to quickly find common ground and solve problems.

• Able to travel (10%-15%) as needed.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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