Principal Biostatistician

SDC•Waltham, MA

1d•Hybrid

About The Position

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. This role applies a high level of technical expertise to help guide and develop more junior biostatistics staff members. The Principal Biostatistician serves as a lead statistician on clinical studies and provides senior-level peer review of work accomplished by other biostatisticians in the department. This role maintains the statistical and analytical integrity of clinical trials analyzed by SDC. The Principal Biostatistician actively participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. This role also supports business development and project management with strategic planning, proposals, pricing, and timeline planning.

Requirements

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.

Responsibilities

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.