Principal Biostatistician

Statistics & Data Corporation (SDC); Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

Generous time off

Attainable career advances

Positive work/life balance

401(k) matching (U.S.)

Job summary

Statistics & Data Corporation (SDC) is seeking a Principal Biostatistician to lead biostatistics on clinical studies and mentor junior staff. You will review SAPs, write statistical sections of protocols and reports, and ensure regulatory compliance while guiding timelines and budgets.

You will also support business development through proposals and capability presentations, acting as a domain expert in client meetings and managing study budgets.

Qualifications

• Master’s degree in biostatistics, statistics, or a related field with four years of relevant professional experience
• PhD in biostatistics, statistics, or a related field with three years of relevant experience
• Equivalent combination of experience and education may be considered

Responsibilities

• Act 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.
• Lead statistician on clinical research projects and assist with SAS programming.
• Provide statistical expertise for study design of clinical trial protocols.
• Write statistical methods sections of study protocols and SAPs as needed.
• Write statistical analysis plans ensuring regulatory requirements and study objectives are followed.
• Review CRFs for protocol and SAP alignment.
• Program summary tables and data listings for trials.
• Perform analyses defined in SAP and post‑hoc analyses.
• Prepare/ review key sections of clinical study reports and regulatory documents.
• Perform statistical QC of outputs.
• Support external clients with statistical questions (FDA, investigators).
• Contribute to SOP development, maintenance, and training.
• Represent biostatistics in regulatory and sponsor meetings.
• Manage biostatistics timelines, budgets, and client expectations.
• Adhere to SDC quality system and data integrity requirements.
• Perform other duties as needed.
• Maintain compliance with regulatory requirements.

Skills

Leadership

Analytical thinking

Independent worker

Project management

Statistical programming

SAS data analysis

Data quality issues

Convey technical concepts

Organization & time management

Regulatory knowledge

Cross-functional collaboration

Quality focus

Education

Master’s degree in biostatistics or related field

PhD in biostatistics or related field

Tools

SAS

Job description

Principal Biostatistician

Statistics & Data Corporation (SDC) is 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 provides a technology‑enabled service offering, combining clinical services expertise with the technology required to achieve success in clinical trials.

Job Summary

Apply a high level of technical expertise to guide and develop junior biostatistics staff. Serve as a lead statistician on clinical studies, providing senior‑level peer review of work by other biostatisticians, maintaining statistical and analytical integrity of trials, and actively participating in writing statistical sections of protocols, statistical analysis plans, and clinical study reports. Support business development and project management through strategic planning, proposals, pricing, and timeline planning.

Primary Responsibilities

• Act 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 sections of study protocols, 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 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 and business ethics requirements.
• Perform other related duties incidental to the work described herein.
• Adhere to all essential systems and processes required at SDC to maintain compliance with business and regulatory requirements.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• 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.
• Ability to identify data issues, present problems, and implement solutions.
• Ability to communicate technical concepts clearly, concisely, and understandably to non‑statistical colleagues and clients.
• Excellent organizational and time‑management skills, with the ability to multitask.
• 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.

Education or Equivalent Experience

Typically a Master’s degree in biostatistics, statistics, or a related scientific field and four years of relevant professional experience; or a PhD in biostatistics, statistics, or a related scientific field and three years of relevant experience; or an equivalent combination of experience, education, and/or demonstrated ability.

Benefits

• Competitive pay
• Generous time off
• Attainable career advances
• Positive work/life balance
• 401(k) matching (U.S.)