Biostatistician II

Job Title: Biostatistician - Clinical Trials (Remote)

Job Description

This role leads complex clinical study work across protocol design, statistical analysis, and interpretation of results, contributing directly to global drug development plans and regulatory submissions. You will act as the primary statistical contact for assigned studies, guide CRO statisticians and programmers, and collaborate with cross‑functional study teams to ensure scientifically sound designs, high‑quality data, and compliant documentation throughout the clinical development lifecycle.

Responsibilities

• Lead statistical activities for complex clinical studies, including study design, protocol development, CRF review, SAP development, and development of analysis datasets.
• Ensure the accuracy and validation of statistical analyses, interpret study results, and provide input and review for clinical study reports.
• Act as the main statistical contact for assigned studies and projects, providing expert statistical guidance to study teams.
• Collaborate closely with data management to ensure high‑quality, reliable, and analysis‑ready data.
• Guide CRO programmers and statisticians in preparing analysis files, performing statistical analyses, and adhering to standards and timelines.
• Contribute to multiple aspects of drug development plans to ensure study designs at each phase are scientifically sound, meet regulatory requirements, and support the intended product profile.
• Apply strong knowledge of pharmacology, clinical research, and medical terminology to inform study design and interpret clinical outcomes.
• Identify, investigate, and resolve complex study issues independently, formulating and proposing effective solutions.
• Develop and execute strategic plans for drug or non‑drug projects, aligning statistical activities with overall development objectives.
• Prioritize multiple tasks and deliverables, develop clear instructions for vendors, and manage external partners to deliver high‑quality outputs on schedule.
• Ensure strict adherence to internal and external compliance practices, SOPs, and GMP-related expectations to maintain the integrity of all work.
• Suggest and implement innovative approaches to improve compliance, documentation standards, and statistical processes.
• Apply strong document classification and data quality practices, including analyzing metadata, categorizing files, and identifying duplicates or misfiled records.
• Maintain accurate and compliant documentation, ensuring correct naming conventions, proper filing, and adherence to retention requirements.
• Communicate statistical concepts, study results, and recommendations clearly to cross‑functional teams and stakeholders, both orally and in writing.
• Stay current with statistical methodologies, evolving drug development trends, and regulatory expectations, and apply this knowledge to ongoing projects.

Essential Skills

• Strong background in biostatistics or statistics with direct experience in clinical trial design and analysis.
• Deep understanding of statistical methodologies relevant to clinical research and drug development.
• Significant knowledge of pharmacology, clinical research processes, and medical terminology for use in study design and results interpretation.
• Working knowledge of clinical trial methodologies and regulated environments.
• Excellent programming skills in SAS and/or R for clinical data analysis and reporting.
• Working knowledge of specialized statistical software such as nQuery, East, or similar tools used for sample size and trial design.
• Experience operating within pharmaceutical or clinical research environments with SOP and GMP knowledge, including compliance and documentation standards.
• Strong document classification and data quality skills, including the ability to analyze metadata, categorize files, and identify duplicates or misfiled records.
• High attention to detail and a strong compliance mindset, ensuring accurate naming conventions, proper filing, and adherence to retention and documentation requirements.
• Strong analytical and problem‑solving skills, with the ability to guide lower‑level biostatisticians in resolving complex issues.
• Ability to identify and investigate issues independently and formulate practical, data‑driven solutions.
• Ability to prioritize multiple tasks and manage vendors effectively to deliver high‑quality outputs on time.
• Strong collaboration and communication skills for working with cross‑functional teams and external stakeholders.
• Excellent oral and written communication skills, including the ability to explain complex statistical concepts clearly.

Additional Skills & Qualifications

• Experience contributing to documents submitted to global health authorities, including statistical sections of regulatory submissions.
• Experience leading statistical activities across the full spectrum of protocol development, CRF review, SAP creation, analysis dataset specification, and CSR input.
• Experience guiding and overseeing CRO statisticians and programmers in the preparation of analysis files and execution of statistical analyses.
• Ability to develop and execute strategic plans for drug or non‑drug projects, aligning statistical deliverables with broader development goals.
• Demonstrated ability to recommend and implement process improvements in statistical workflows, documentation, and compliance practices.
• Familiarity with current drug development trends and evolving regulatory environments.
• Oncology clinical trial experience (preferred).

Work Environment

This is a 100% remote position, offering the flexibility to work from your preferred location while collaborating closely with global, cross‑functional teams and external CRO partners. You will work extensively with statistical programming tools such as SAS and R, as well as specialized software like nQuery and East, within a structured environment governed by SOPs, GMP principles, and strict documentation and compliance standards. Communication with colleagues and stakeholders will occur primarily through virtual meetings, digital collaboration platforms, and shared electronic document management systems, with a strong emphasis on organized, accurate, and compliant electronic records.

Job Type & Location

This is a Contract position based out of Basking Ridge, NJ.

Pay and Benefits

The pay range for this position is $90.00 - $90.00/hr.

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 is anticipated to close on Jul 13, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.