Biostatistician II

🔥 0 minutes ago

🌲 North Carolina – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Function independently as a lead statistician with minimal oversight • Deliver project statistician tasks and responsibilities, including analysis database creation, statistical analyses, and formatted statistical analysis tables and summaries • Provide mentorship to junior team members • Ensure compliance with departmental SOPs and procedures • Lead project teams, conduct meetings, maintain timelines, assess resources, prepare budgets, and maintain project documentation • Interact with sponsors on all aspects of projects • Coordinate with programmers and data management personnel on database maintenance, updates, and documentation • Guide database structures for analysis • Provide sample size calculations and review protocols for clinical design and statistical analysis • Provide randomization schemes and documentation • Develop statistical analysis plans, analysis databases, and table/listing specifications • Guide team members in implementing statistical analysis plans • Program and validate statistical tables, emphasizing efficacy endpoints • Document and oversee programming and validation work • Review reports, documents, and manuscripts • Contribute to statistical methods sections and verify report completeness and consistency • Monitor project budgets against work scope and communicate potential scope changes to management • Provide department infrastructure support, including presentations, teaching, policy/document contributions, newsletters, department libraries, and new-hire training

🎯 Requirements

• Masters in Biostatistics, Statistics or Math at a minimum is required • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Previous experience comparable to 2+ years • Project lead client facing experience is required • Experience programming in SAS and R is required • Strong knowledge of SAS® and clinical biostatistics • Strong understanding of the drug development process and FDA regulations • Demonstrated initiative and motivation • Capable of leading complex projects • Effective management skills, including successful management of multiple projects and staff members • Proven ability to mentor and motivate staff • Strong verbal and written communication skills • Ability to proactively direct and promote teamwork in a multi-disciplinary team setting • Capable of managing change and uncertainty to optimize positive outcomes • Ability to make independent judgments under limited supervision • Strong interpersonal skills and a collaborative team-oriented mindset • Must be legally authorized to work in the US without sponsorship • Must be able to pass a comprehensive background check, including a drug screening

🏖️ Benefits

• Relocation assistance is NOT provided • Reasonable accommodation for individuals with disabilities during the application, interview, and employment process • Accessibility service for job seekers requiring accommodations in the application process

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