Senior/Director of Biostatistics – Rare Disease – Fsp

Senior/Director of Biostatistics – Rare Disease – Fsp

Requirements

• MS or PhD degree in Biostatistics or a related field and 10+ years’ relevant experience within the life-science industry. PhD preferred.
• Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials.
• Expert in strategically collaborating with clinical and drug development experts.
• Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries.
• Strong understanding of multiple imputation methodologies.
• In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (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.

Responsibilities

• Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
• Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee.
• Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, analysis plans, and writing sections of clinical/statistical reports, integrated summaries, and/or NDA sections.
• Lead development programs at a strategic level, to understand the asset well and maximize its chances of success.
• Provide expert review and initiate methodology work with regards to statistical standards and regulatory.
• Consult on strategic/operational/statistical/therapeutic area topics.
• May represent sponsor and biostatistics to Health Authorities and Reimbursement/Payer Organizations or internal governance committees.
• Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.
• Perform as subject matter expert (SME).
• Proactively identify risks to project delivery, success and quality, lead in a way to minimize these risks, to avert escalations, support leads in implementing risk mitigation actions.
• Provide expert statistical input into the review of statistical deliverables (i.e., statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports).
• Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data).
• Provide expert review of ADaM reviewers guide (ADRG) and metadata.
• Perform senior biostatistical review (SBR).
• Produce or perform quality control review of sample size calculations for complex studies.
• Statistical problem-solving skills to overcome data or analytical challenges.

Preferred Qualifications

• Rare disease and immunology experience is greatly preferred.