Principal Biostatistician

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Utilize extensive technical expertise to mentor and guide junior members of the biostatistics team.

• Act as the principal statistician for clinical studies and provide senior-level peer review of the work carried out by other biostatisticians in the department.

• Ensure the statistical and analytical integrity of clinical trials analyzed by SDC.

• Engage in writing statistical sections of protocols, developing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, composing statistical sections of clinical study reports, and participating in meetings with regulatory agencies as necessary.

• Assist with business development and project management through strategic planning, proposal writing, pricing, and timeline development.

• Serve as an internal consultant for biostatistical analysis tools and methodologies.

• Function as a subject matter expert in biostatistical analysis support during client and vendor meetings.

• Actively aid in business development by delivering capabilities presentations to both prospective and existing clients.

• Efficiently manage budgets for biostatistical analysis support related to assigned clinical studies.

• Mentor, develop, and coach junior personnel within the biostatistics department.

• Lead statistician for clinical research projects, assisting with SAS programming as needed.

• Provide statistical expertise in the design of clinical trial protocols.

• Draft the statistical methods section of the study protocol when necessary.

• Create statistical analysis plans that adhere to the relevant regulatory requirements and study objectives outlined in the study protocol.

• Review CRFs to ensure alignment with the protocol and the statistical analysis plan (SAP).

• Program summary tables, data listings, and graphical representations of clinical trial data.

• Execute all analyses specified in the statistical analysis plan, including any post-hoc and relevant exploratory analyses of clinical trial data.

• Prepare and review key sections of clinical study reports and various regulatory documentation.

• Conduct statistical quality control of all department outputs, including analyses and clinical study reports.

• Provide statistical support to address inquiries from external clients (such as the FDA and 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 gatherings as required.

• Oversee biostatistical timelines, budgets, and client expectations.

• Adhere to all standards of the Statistics & Data Corporation’s quality system.

• Comply with the data integrity and business ethics requirements of Statistics & Data Corporation.

• Perform additional related duties as necessary for the role.

⛳️ Requirements

• Strong leadership, budget forecasting, and implementation capabilities.

• Exceptional analytical skills with the ability to process scientific and medical data.

• Ability to work independently as well as collaboratively within teams.

• Proficient project management skills, including analytical evaluation, organization, delegation, flexible team management, negotiation, and resource management.

• Extensive knowledge of statistical programming.

• Expertise in manipulating and analyzing SAS data.

• Skilled at identifying data issues, presenting challenges, and implementing solutions.

• Capable of communicating complex technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients.

• Excellent organizational and time management skills, with the ability to handle multiple tasks simultaneously.

• Familiarity with clinical trial design and analysis activities, along with a basic understanding of regulatory guidelines (FDA/CFR, ICH/GCP).

• Strong interpersonal communication and presentation abilities.

• Able to effectively collaborate across cross-functional teams.

• Committed to maintaining quality in all situations and tasks.

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

🏝️ Benefits

• We are dedicated to the development of our employees, recognizing achievements, providing growth opportunities and pathways for career advancement, along with a flexible work schedule, engaging work culture, and comprehensive employee benefits.

• Our company culture is a source of pride. Our recognition program aligns directly with our core values: Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We aim to foster a sense of belonging among employees through enjoyable and engaging activities organized by SDC’s culture club.

• We continuously evolve and innovate to meet the needs of our clients and employees. Our global presence allows us to incorporate diverse perspectives that drive our growth in this dynamic industry.

• Since 2005, SDC has built a successful track record in executing client clinical programs.