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Director / Sr. Director of Biostatistics

2 months ago

Boston, United States Softworld Inc Full time

Job Title: Sr. Director of Biostatistics

Job Location: Boston MA 02215

Onsite Requirements:

Late Phase
Adaptive Design
Oncology

Job Description:

Reporting to the Vice President, Biometrics you will be working with cross functional clinical teams responsible for statistical activities across client's clinical programs, including overseeing statistical deliverables outsourced to clinical CROs.
This is an exciting opportunity to make an impact in the development of transformative therapies that may change patients' lives.
The ideal candidate is a good communicator, collaborative, self-motivated, and forward thinking.

Your Role:

You will serve as a biostatistics expert for client's clinical programs
Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables
Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
Provide statistical input for clinical documents
Perform QC/QA of statistical deliverables including validation of key analysis results
Perform ad hoc statistical analyses as needed
Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations
Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
Represent client regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
Support inspection readiness activities as needed
Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
Additional duties and responsibilities as required

What You Bring:

PhD in statistics or related discipline; MS with appropriate years of directly relevant experience
At least 8 years' experience in the pharmaceutical or biotech industry
Experience in the design, analysis, and reporting of clinical trials
Experience in INDs, NDAs, MAAs, or other regulatory submissions
In-depth knowledge of statistical methods for clinical trials
Knowledge of FDA, EMA, and ICH regulations and guidelines
Proficient in statistical programming (SAS and R)
Ability to lead statistical efforts for multiple studies
Fluent in data standards, including SDTM and ADaM
Experience in outsourced statistical services provided by CROs
Ability to work independently and act with initiative to address issues
Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner