Associate Director, Biostatistics

The Associate Director, Biostatistics, provides statistical support in one or more clinical trials. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical development team to support protocol design. Evaluates databases and statistical analysis programs. Maintains expertise in state-of-the-art data statistical methodologies and statistical analyses. At the project level, the individual in this role ensures the study designs are scientifically sound and that the efficacy and safety endpoints meet regulatory requirements.

Responsibilities

Provide assistant statistical support to compound statistical leader for clinical development plan for clinical trials; At study level, provide statistical input to study protocols, develop statistical analysis plan, tables/listings/figures, and database monitoring and lock activities; Serve as biostatistics lead for assigned clinical studies, publications, and conference presentations, as needed; Assist in writing relevant sections of the clinical study report and publications; Monitor and guide internal biometrics team and CRO project activities including timelines, deliverables and resources; Participate in pre-IND and NDA/BLA activities; Use SAS to perform efficacy analyses and validate important data derivations when necessary; Develop and implement department standards and lead process improvements

Requirements

PhD or MS in Biostatistics or Statistics; At least three years' experience for PhD, or five years' experience for MS as statistician in the pharmaceutical or biotechnology industry; Knowledge of advanced study design and up-to-date biostatistical methodologies; Experience as an independent statistician with responsibility for multiple studies or projects; Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively; Good knowledge of statistical programming languages (including SAS); Knowledge of SDTM/ADaM

Nice to have

Oncology (especially solid tumor) clinical trial experience; Experience of NDA/BLA eCTDs or other global regulatory submissions

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown