Job Description

Job Title: Biostatistician Job Description This position is home-based in the U.S. or Canada, with a preference for candidates located on the East Coast. The role involves serving as a strategic and operational counterpart to a customer's biostatistics team, fully integrating into their clinical development framework. The primary responsibility is to provide statistical leadership, ensuring alignment with customer standards, timelines, and strategic objectives across assigned clinical programs. Responsibilities Liaise with cross‑functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the customer's biostatistical department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, contributing to clinical development plans, and responding to regulatory queries. Provide statistical leadership in submission activities, including the development and production of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) documents. Lead the development and refinement of Statistical Analysis Plans (SAPs) in coordination with the customer's biostatistics and clinical stakeholders. Provide statistical input into protocol design, amendments, and other key study documents. Ensure scientific rigor in statistical methodologies. Monitor and explore blinded data during study conduct to support strategic decision‑making and identify intercurrent events. Mentor and guide the biostatistics and programming team to align with customer standards and expectations. Partner with the customer's statistical programming team and biostatisticians to plan and execute dry run activities, ensuring readiness for database lock and final analysis. Review and validate key statistical outputs including TLFs (Tables, Listings, Figures), and final study reports. Support interpretation of statistical results and contribute to data‑driven decision‑making. Act as an extension of the customer's biostatistics function, preparing materials, conducting exploratory analyses, and troubleshooting data or methodological issues. Facilitate efficient communication and coordination between teams to maintain alignment and responsiveness. Ensure deliverables meet quality standards and comply with regulatory guidelines. Maintain alignment with customer processes, templates, and documentation standards. Essential Skills MS or PhD degree in Biostatistics or a related field and 8+ years' relevant experience within the life‑science industry. Expert in a broad range of complex statistical methods applicable to Phase 2‑3 clinical trials. Expertise in strategically collaborating with clinical and drug development experts. Experience as a statistical lead for regulatory submissions, including preparation of submission datasets and responding to regulatory queries. In‑depth knowledge of clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonisation (ICH) guidelines. Strong working knowledge of SAS or R. Excellent knowledge of CDISC Data standards. Superb communication and collaboration skills. Independent and proactive problem‑solving skills. Additional Skills & Qualifications Experience in rare diseases and immunology is greatly preferred. Work Environment This is a home‑based position, with a preference for candidates on the East Coast of the U.S. or Canada. The role involves collaboration with a sponsor located in Europe. Candidates will work in a collaborative, cross‑functional team environment, utilizing statistical software such as SAS or R, and adhering to rigorous regulatory standards to ensure quality and compliance in all deliverables. Job Type & Location This is a Contract position based out of Durham, NC. Pay and Benefits The pay range for this position is $60.00 - $61.00/hr. 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 Apr 10, 2026. Diversity, Equity & Inclusion 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com. #J-18808-Ljbffr

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