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Company

Neumora · 7 hours ago

Director, Biostatistics

United States

Full-time

Remote

Director/Executive

$226K/yr - $239K/yr

10+ years exp

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Responsibilities

Participate in the discussion and contribute to the creation of clinical development plans for the assigned compound(s).

Collaborate with cross-functional experts on clinical trial designs from objectives to sample size.

Contribute to protocol development including authoring statistical methods section and reviewing the protocol throughout.

Ensure the accuracy of randomization schedule and contribute to eCRF design such that data collection closely supports trial design intent.

Develop and finalize study Statistical Analysis Plan (SAP) and the related shells for table/listing/figure (TLF).

Hold the primary responsibilities of managing statistical vendor(s) to implement SAP and deliver study results of high quality in a timely manner.

Hold the primary responsibilities of managing statistical vendor(s) to deliver other data analyses, as needed, while the trial is being conducted (e.g., DMC support, or interim analysis).

Contribute to any forms of data dissemination, including clinical study reports, regulatory documents, and publications.

Develop SAP and related shells for TLFs for integrated data analysis, as needed; work with statistical vendor(s) to implement the SAP and deliver the results for integrated data analysis.

As an important player in the potential regulatory filing preparation team, contribute to the dossier creation and review.

Write own SAS programs when necessary for the purpose of analysis or validation.

Contribute to Biometrics SOPs development.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Statistics/BiostatisticsClinical Trial DesignStatistical Analysis Plan (SAP)SAS ProgrammingStatistical Vendor ManagementStatistical MethodsIntegrated Data AnalysisRegulatory Guidance KnowledgeProject Management SkillsProblem-Solving AbilityTime Management SkillsCollaboration Skills

Required

A PhD degree in statistics or biostatistics with at least 10 years’ experience in clinical trial design, analysis and reporting.

Solid statistical knowledge and experience in clinical trial design (early or late phase).

Proven record of using statistical methods to solve real world problems and support a compound’s advancement.

Rich experience in study SAP and TLF shells development.

Experience working with statistical vendors to implement the SAP and deliver with quality and speed.

Solid knowledge of SAS or R statistical computational language.

Working knowledge of regulatory guidance relevant to clinical trials from design to analysis.

Demonstrated ability to collaborate with Clinical Development, Clinical Operations, Regulatory Affairs and other relevant functions to deliver common goals.

Experience in integrated data analysis and NDA/BLA/MAA filing.

Demonstrated problem-solving ability and interest in continued learning.

Strong organizational skills, project management skills, and time management skills.

Detail-oriented and holds high standards of excellence for own work product.

Ability to deliver and communicate effectively in the work-from-home environment.

Excellent interpersonal skills and a good team player.