Principal Biostatistician

Job Title: Principal Biostatistician

Job Description

We are seeking a highly skilled Principal Biostatistician to join our team. In this role, you will leverage your statistical expertise to develop complex analysis strategies and execute them using efficient programming techniques. You will provide input to analysis plans, protocol design, statistical reports, and clinical reports. As a proactive advisor, you will guide analysis throughout the project life cycle, ensure quality control of statistical deliverables, and mentor junior team members. Additionally, you will develop and modify department SOPs and work instructions.
Responsibilities

• Execute intricate statistical analyses and provide input to statistical reports.
• Investigate novel approaches for designing and analyzing clinical research studies.
• Act as the primary statistician on assigned projects from initial protocol design to final submissions to regulatory bodies.
• Review and provide input on case report forms (CRFs), database validation checks, and CRF completion instructions.
• Produce randomization schedules and lead blinding and unblinding processes.
• Develop and review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) and table, listing, and figure (TLF) shells as needed.
• Perform statistical analysis by independently programming and cleaning derived datasets and TLFs; validate the programs per department SOPs.
• Develop statistical methods and results sections of statistical reports, clinical study reports (CSR), and manuscripts.
• Develop and perform descriptive and imputation data analyses.
• Interact with Data and Safety Monitoring Boards (DSMBs), including presenting interim study progress.
• Act as a statistical consultant within the Patient Outcomes and Experience department and to other departments, advising on proper statistical methodology and techniques.

Essential Skills

• Advanced knowledge and experience in clinical trial methodology.
• Experience and knowledge of clinical data management processes and tools (Medidata Rave and Veeva preferred).
• Practical understanding of fundamental statistical concepts and methodologies.
• Proven knowledge of research study design methods and independent problem solving.
• Ability to explain statistical concepts to non-statisticians.
• Proficiency in statistical methods used to design and assess outcomes of clinical trials.
• Strong research and analysis skills, including an understanding of scientific/therapeutic research.
• High-level experience with SAS programming and statistical analysis.
• Excellent problem-solving skills and a positive attitude.
• Strong written and communication skills, with meticulous documentation of processes.
• Organizational skills and ability to manage multiple projects while meeting deadlines.
• Basic Microsoft Office and Internet skills.
• Ability to commit to occasional overnight travel.

Additional Skills & Qualifications

• PhD degree in a relevant field with 3+ years of experience in statistical design and analysis of clinical or biomedical studies.
• Preference given to candidates with working knowledge of GCP and FDA regulations.
• Experience working in the pharmaceutical/medical device industry.
• Working knowledge of SDTM.

Work Environment

Our work environment encourages collaboration and continuous learning. You will have access to advanced technologies and tools to support your research and analysis. The role may require occasional overnight travel.
Pay and Benefits

The pay range for this position is $145000.00 - $155000.00/yr.
Full Company Benefits. 8% bonus.
Workplace Type

This is a fully remote position.
Application Deadline

This position is anticipated to close on Apr 28, 2025.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.