Biostatistician

Job Description

We are a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We work with many of the most advanced drugs, biologics, and medical devices in development today. We have been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, we have successfully developed and established ourselves as a full-service CRO. We are known in the industry for high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. We continue to experience exceptional growth and great success. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Principal Biostatistician.

Responsibilities

• Manage clinical trial programs/projects from one or multiple clients.
• Provide day-to-day technical and operational leadership to project teams.
• Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
• Coach, mentor, and develop less experienced Biostatisticians and Statistical Programmers.
• Provide statistical input in protocol design and development.
• Participate in the writing of trial protocols.
• Review and provide input to clinical data management deliverables.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
• Perform peer review of SAPs and other technical documents.
• Perform hands-on statistical analysis and modeling.
• Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians.
• Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results.
• Perform statistical and programming resource management, capacity analysis, benchmarking, and metrics.
• Participate in the continuous improvement and maintenance of statistical and programming governing documents.
• Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Essential Skills

• Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience OR a Master’s degree in these fields with at least 10 years of relevant experience.
• Exceptional ability and performance in statistical analysis.
• Experience with a CRO.
• Proficiency in statistical methodologies and regulatory requirements.
• Expertise in statistical modeling and analysis.

Pay and Benefits

The pay range for this position is $65.00 - $100.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 31, 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.

Salary : $65 - $100