Associate Director, Biostatistics

Replimune•Woburn, MA

1d•$193,500 - $250,500•Hybrid

About The Position

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. This position can be based either in our Woburn office or be a remote role. Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 15-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Requirements

PhD or MS in Biostatistics or Statistics required
At least three (3) years’ experience for PhD, or five (5) 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 Haves

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

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
Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
Develop and implement department standards and lead process improvements
Other duties as assigned