Midsize Oncology focused Biotech company experiencing growth within their Biostatistics department; looking to bring on an Associate Director, Biostatistics to their team.
* Works with project team members and manage CROs to generate clinical protocol, authors statistical analysis plan/TLF templates, specifications, CRFs, and CRF edit checks.
* Performs analysis, interpret study results, and collaborates with clinical team to produce interim reports, final reports, and publications.
* Effectively manages CRO to ensure high-quality deliverables within timeline and budget.
* Responsible for one more studies with concurrent tasks and timelines.
* Participates in the validation/QC of key study endpoint analysis and submission deliverables.
* Applies appropriate regulatory guidelines to the projects.
* Supports on-going publication tasks to ensure smooth communication of outputs required between medical affairs, biostats and programming.
* MS/MA degree in related discipline and eight years of related experience; or,
* PhD in related discipline and five years of related experience,
* Experience in oncology and study Phases I-IV highly preferred.
* Experience in Biotech/Pharmaceutical industry preferred.
* Experience with managing CROs in the conduct of clinical trials.
* Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
* Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
* Knowledge of appropriate regulations, industry standards and guidance documents.
* Ability to interact effectively with biostatistical, data management, operations and clinical personnel from CROs and companies collaborating .
* Developed/reviewed SDTM/ADaM specifications.
* Strong SAS programming knowledge preferred.