Senior Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the Biostatistician role by offering technical expertise as a key member of complex clinical studies, which includes statistical oversight and participation in relevant project meetings.

• Deliver advanced statistical insights and thought leadership for innovative study designs and clinical development plans, covering aspects such as endpoint selection, estimands, sample size and power, as well as analysis methods.

• Craft the statistical sections of study protocols, statistical analysis plans, and other related documents.

• Analyze results and conduct a comprehensive statistical review of tables, figures, and listings to guarantee accurate and consistent reporting in study reports and regulatory documents.

• Collaborate with statistical programmers to set priorities, manage timelines, assess deliverable quality, and address issues impacting project objectives.

• Aid in regulatory submissions and responses by preparing and reviewing statistical analyses, summaries, and supporting documentation in conjunction with Regulatory, Clinical, and other stakeholders.

• Assist with the preparation of abstracts, oral presentations, manuscripts, and written reports.

• Offer statistical expertise to both internal and external stakeholders, including in presentations/publications, Marketing, and Health Economics & Reimbursement.

• Develop, maintain, and implement biostatistics SOPs, processes, standards, and work instructions.

⛳️ Requirements

• A Master's degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science, or Mathematics.

• 6+ years of relevant experience with a Master's Degree; or 3+ years with a PhD; or equivalent experience.

• In-depth understanding of related aspects of biostatistics processes and systems.

• Exceptional written and verbal communication skills, with the ability to professionally interact at all organizational levels to ensure the achievement of deliverables.

• Strong interpersonal and relationship management abilities, including a proactive approach to elevating and resolving cross-functional issues to meet project objectives.

• Extensive organizational, judgment, analytical, decision-making, and influencing skills.

• Proficient understanding of clinical trial design, with the ability to apply functional knowledge and methodologies to tackle complex problems.

• Capability to cultivate effective peer, cross-functional, and cross-business relationships to enhance best practice sharing and team effectiveness.

• Ability to excel in a fast-paced, dynamic, and ever-changing work environment.

• Strong programming skills in R (mandatory) and Python (preferred).

• Demonstrated proficiency in literate programming (R markdown/Sweave).

• A Ph.D. or higher in Statistics, Biostatistics, or Mathematics (desirable).

• Experience leading IVD clinical Biostatistics for FDA submissions (desirable).

• Familiarity with CDISC requirements is preferred.

🏝️ Benefits

• Equity

• Cash bonuses

• Comprehensive medical, financial, and other benefits

• Commitment to equal opportunity and diversity