Role Overview

Serve as an internal consultant for biostatistics analysis tools and methods
Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
Actively support business development in capabilities presentations to prospective and current clients
Effectively manage assigned clinical study budgets for biostatistics analysis support
Develop, coach and mentor junior biostatistics department personnel
Act as the lead statistician on clinical research projects and help with SAS programming
Provide statistical expertise for study design of clinical trial protocols
Write statistical methods section of the study protocol, as needed
Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
Program summary tables, data listings and graphical representations of clinical trials data
Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
Prepare/review key sections of clinical study reports and various regulatory documents
Perform statistical QC of all department outputs including analyses and clinical study reports
Provide statistical support to answer questions from external clients (such as FDA, Investigators)
Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
Manage biostatistics timelines, budgets, and client expectations
Adhere to all aspects of the Statistics & Data Corporation’s quality system
Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Requirements

Experience leading ISS/ISE submissions
Effective leadership, budget forecast and implementation skills
Excellent analytical skills, with the ability to process scientific and medical data
Able to work independently and in teams
Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
Excellent knowledge of statistical programming
Expertise in manipulating and analyzing SAS data
Able to identify data issues, present problems, and implement solutions.
Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients
Excellent organizational and time management skills, with the ability to multi-task
Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
Strong interpersonal communication and presentation skills
Able to effectively collaborate across cross-functional teams
Focus on quality at all times and in all situations
A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience.

Tech Stack

Google Cloud Platform

Benefits

We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
With a proven track record, SDC has been successfully executing client clinical programs since 2005.

SDC (Statistics & Data Corporation)

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Other

Principal Biostatistician