Director Biostatistics

Director, Biostatistics

Benefits : 20 Days PTO

20 Days PTO

1 Week of mental tranquility / sick time

1 Week : Christmas-New Years break (company shut down)

Base Salary + Performance based bonus

100% Paid : Full Medical Plan for employee

401K Plan

Development & Training to facilitate career growth

Hybrid & Flexible Work Schedule

Bring your pet to work

Responsibilities :

This position will contribute to the clinical program, departmental and cross-functional initiatives by working closely with the clinical study team including the medical director, clinical trial management, data management, and other clinical study personnel.

This role will oversee outsourced activities and deliverables from biostatistics and programming roles, ensuring on time execution and that deliverables are of high quality and met according to the study plan.

The Director, Biostatistics will provide statistical and programming expertise to the development of clinical study designs and in performing data analysis, providing data interpretation and graphical / summary outputs, and contributing to clinical publications and regulatory submissions.

• Collaborate with the clinical development team in designing clinical trials ensuring that statistical principles are applied appropriately.
• Support the clinical development team in global Health Authority interactions as the Biostatistics representative.
• Responsible for randomization plans, where applicable.
• Collaborate with data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
• Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM / ADaM datasets, etc.
• Provide scientifically rigorous statistical input and review of clinical protocols, interpretation of statistical results and scientific publications.
• Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs.

Participate in regularly scheduled meetings that require statistical input.

• Develop strategies to address health authorities’ inquiries pertaining to biostatistics.
• Provide programming support across development to support delivery of summarized tabular / graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses.
• Maintain and modify in-house code.

Qualifications :

• Familiarity with GCP, ICH and FDA requirements required
• Masters in Statistics / Biostatistics with 7+years of directly relevant experience required.
• Strong R programming skills are required.
• Experienced in SAS preferred
• Experience required in oncology therapeutic area
• Prior experience supporting a BLA or NDA filing and representing biostatistics in interactions with health authorities required.
• Able to examine relevant data and quickly develop an analysis plan that will answer key business questions.
• Understanding of clinical or advanced statistics such as regression, time-series forecasting, clustering, decision trees, exploratory data analysis methodology in general, scenario analysis, modeling, optimization, and unstructured data analysis
• Experience in working with clinical database software and data structures, especially Medidata RAVE
• Knowledge of and experience with CDISC standards and validation processes required
30+ days ago