Biostatistics Director – Global BIOS

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Act as a thought leader in statistical methodologies for the design of clinical trials.

• Offer high-level statistical consultancy and support to both internal and external clients.

• Specialize in at least one domain of statistical leadership and function as a subject matter expert.

• Lead statistical leadership initiatives while providing general consulting as required.

• Engage in data monitoring committees in either a blinded or unblinded capacity.

• Assist in drafting protocol synopses in collaboration with medical, pharmacokinetic, and operational specialists.

• Occasionally contribute to complete protocols and provide consultation on advanced statistical analyses.

• Publish research in peer-reviewed journals and engage in referee and editorial duties.

• Deliver presentations at scientific conferences and participate in invitation-only webinars.

• Oversee teams and projects based on personal interest.

• Take part in bid defenses as necessary.

• Travel to client locations as required.

⛳️ Requirements

• PhD or MSc in Statistics, Biostatistics, or a related discipline, with 11 to 13+ years of experience in the life sciences sector; PhD is preferred.

• In-depth knowledge of complex statistical methods applicable to clinical trials.

• Proven experience in clinical trial design; familiarity with adaptive design is highly preferred.

• Understanding of regulatory agencies and compliance within the pharmaceutical and CRO environments; FDA experience is preferred.

• Strong proficiency in SAS and CDISC SDTM and ADaM standards.

• Capacity to effectively manage multiple tasks and projects simultaneously.

• Proficient in communicating and clarifying statistical concepts.

• Experience in preparing budgets/proposals and engaging in bid defenses.

• Background in publishing research or delivering presentations at scientific conferences and/or webinars.

🏝️ Benefits

• Engaging and innovative projects.

• Collaborative and motivating working environment.

• Excellent opportunities for career development and advancement.

• Emphasis on work-life balance.

• Potential for incentive plans, bonuses, and/or other compensation options.

• Health and welfare benefits and/or additional perks may be offered.