Senior 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.
• Act as a Senior Reviewing Biostatistician on SAPs created by other team members. Develop statistical analysis plans if needed, 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.
• 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 and quality audits related to biostatistics activities at TD2.
• 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 5 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 4 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.

#LI-TD2

#LI-Remote