Sr. Manager, Biostatistics
Overview:
The Director, Biostatistics, provides statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials.
Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials.
Interacts with clinical development team to determine 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 requirementsThis position can be based either in our Woburn office or be a remote role Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Remote candidates (i.
e.
, living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.
Responsibilities:
Provide statistical support to clinical development plan for multiple clinical trials At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures Assist in writing relevant sections of the clinical study report and publications Monitor and guide internal 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
Responsibilities:
Other duties as assigned
Qualifications:
Education Requirements:
PhD or MS in Biostatistics or Statistics requiredExperience and Skill Requirements:
At least seven (7) years experience for PhD, or nine (9) years experience for MS as statistician in the pharmaceutical or biotechnology industry.
Oncology (especially solid tumor) clinical trail experience preferred; knowledge of immuno-oncology is a plus.
Experience with advanced study design and up-to-date biostatistical methodologies.
Experience of NDA/BLA eCTDs or other global regulatory submissions.
Experience of direct interaction with health authorities.
Experience as an independent lead 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.
Please note:
Candidates must be local or open to relocating as remote is not an option for some roles.
Woburn Location:
Local candidates are expected to be on-site 2 days per week.
Non-local candidates open to 10-25% travel to Woburn officeReplimune is an equal opportunity employer.
Replimune now requires COVID vaccination disclosure for all US employees Recommended Skills Biotechnology Business Requirements Clinical Study Reports Clinical Trials Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
The Director, Biostatistics, provides statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials.
Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials.
Interacts with clinical development team to determine 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 requirementsThis position can be based either in our Woburn office or be a remote role Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
Remote candidates (i.
e.
, living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.
Responsibilities:
Provide statistical support to clinical development plan for multiple clinical trials At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures Assist in writing relevant sections of the clinical study report and publications Monitor and guide internal 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
Responsibilities:
Other duties as assigned
Qualifications:
Education Requirements:
PhD or MS in Biostatistics or Statistics requiredExperience and Skill Requirements:
At least seven (7) years experience for PhD, or nine (9) years experience for MS as statistician in the pharmaceutical or biotechnology industry.
Oncology (especially solid tumor) clinical trail experience preferred; knowledge of immuno-oncology is a plus.
Experience with advanced study design and up-to-date biostatistical methodologies.
Experience of NDA/BLA eCTDs or other global regulatory submissions.
Experience of direct interaction with health authorities.
Experience as an independent lead 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.
Please note:
Candidates must be local or open to relocating as remote is not an option for some roles.
Woburn Location:
Local candidates are expected to be on-site 2 days per week.
Non-local candidates open to 10-25% travel to Woburn officeReplimune is an equal opportunity employer.
Replimune now requires COVID vaccination disclosure for all US employees Recommended Skills Biotechnology Business Requirements Clinical Study Reports Clinical Trials Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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