Biostatistician CONSULTANT

CONSULTANT - BIOSTATISTICIAN ROLE Estimated Commitment: Average: 2-3 hours per week Increased support required during key study milestones Job Description We are seeking a skilled Biostatistician to provide statistical input for clinical study design, protocol development, and review. You will be involved in endpoint selection, sample size justification, and randomization strategies, as well as PK/PD and exposure-response analyses. You will also author and review Statistical Analysis Plans (SAPs) and interpret and validate Tables, Listings, and Figures (TLFs). You will support the preparation and review of Clinical Study Reports (CSRs) and regulatory submission documents, and perform ad hoc analyses including efficacy and safety analyses, subgroup analyses, PK/PD modeling support, and data trending and exploratory analyses. Responsibilities Provide statistical input for clinical study design and protocol development. Develop endpoint selection and sample size justification strategies. Design randomization strategies and conduct PK/PD and exposure-response analyses. Author and review Statistical Analysis Plans (SAPs). Review, interpret, and validate Tables, Listings, and Figures (TLFs). Support the preparation and review of Clinical Study Reports (CSRs) and regulatory submission documents. Perform ad hoc analyses, including efficacy and safety analyses, subgroup analyses, and PK/PD modeling support. Conduct exposure-response assessments and data trending and exploratory analyses. Essential Skills Expertise in biostatistics. Experience in clinical trial biostatistics. Proficiency in SAP authoring and statistical analysis planning. Ability to review and interpret TLFs. CSR and regulatory submission support experience. PK/PD and exposure-response analysis expertise. Additional Skills & Qualifications Ability to communicate statistical findings to both technical and non-technical stakeholders. Collaborative skills to work with Clinical Development, Clinical Pharmacology, Data Management, Programming, and Regulatory teams. Work Environment This position is 100% remote, allowing for flexibility and work-life balance. Job Type & Location This is a Contract position based out of Warren, NJ. Pay and Benefits The pay range for this position is $90.00 - $100.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Sep 11, 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.