Director, Biostatistics

Kaztronix

Miami, FL(remote)

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JOB DETAILS

SKILLS

Bayesian Networks, Biometrics, Biostatistics, Biotech and Pharmaceutical, Clinical Data Interchange Standards Consortium (CDISC), Clinical Practices/Protocols, Clinical Support, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Management, Delivery Management, Develop Methodologies, Drug Development, FDA (Food and Drug Administration), GCP (Good Clinical Practices), ICH Regulations, Leadership, Medical Affairs, Operational Support, Presentation/Verbal Skills, Procedure Implementation, Protocol Design, R Programming Language, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Submissions, Statements on Auditing Standards (SAS), Team Player, Technical Leadership, Translational Research, Willing to Travel, Writing Skills

LOCATION

Miami, FL(remote)

POSTED

30+ days ago

Director, Biostatistics

Job Summary:
We are seeking an experienced Director of Biostatistics to provide scientific and technical leadership for our clinical development programs. In this role, you will lead all biostatistical activities and serve as a biostatistical expert across all assigned projects, ensuring the highest standards of scientific rigor and regulatory compliance.
Key Responsibilities:
" Provide statistical leadership and support across all clinical development functions and lead all assigned projects within the Biometrics department.
" Participate and interact with clinical and cross-functional teams in the development of protocols, study design, and endpoints discussions.
" Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents.
" Apply advanced statistical methodologies, such as survival analysis, Bayesian analysis, handling missing data and adaptive designs.
" Provide statistical support to Clinical Operations, Regulatory Affairs, Medical Affairs, Translational science, and RWE functions.
" Support regulatory submissions work and generation of ISS/Client.
" Ensure consistency within Biometrics functions, including Programming and Data Management, for all deliverables to enhance efficiency and quality.
" Represent Biostatistics in meetings with regulatory authorities.
" Develop and implement departmental SOPs for statistical activities in accordance with ICH, GCP, guidelines, and CDISC standards (SDTM/ADaM).
" Manage and oversee the work of CROs and other external vendors to ensure the quality and timeliness of deliverables.
Qualifications, Experience, & Competencies:
" A master s or PhD degree in biostatistics or a related field is required.
" At least 10 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry is essential.
" Proficiency in SAS and/or R. Familiarity with CDISC standards (SDTM, ADaM) is essential.
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" In-depth experience and expertise in applying biostatistical methodologies to clinical development are highly desirable.
" Understanding of FDA, EMA and ICH regulations and guidelines. Experience working on regulatory submissions is preferred.
" Excellent verbal and written communication skills are essential, along with the ability to work effectively as part of a team.
" Must be able to work independently with minimal supervision.
" Additionally, the ability to travel up to 5% of the time, depending on the business s needs, is required.

About the Company

Kaztronix

Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.kaztronix.com/