Job Overview:

As Biostatistics Director, you will liaise with cross-functional teams to drive the quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.

Key Responsibilities:

Leadership:

1. Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
2. Represent sponsors at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee.
3. Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.
4. Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries, and/or NDA sections.
5. Lead studies at an operational level.
6. Provide expert review and initiate methodology development work regarding statistical standards and validation procedures.
7. Consult on operational/statistical/therapeutic area topics.

Knowledge Sharing:

1. Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.
2. Perform as subject matter expert (SME).

Risk Management:

1. Identify risks to project delivery and/or quality, leading in a way to minimize risks.
2. Anticipate risks to avert the need for study-level escalations, supporting leads in implementing risk mitigation actions.

Lock and Unblinding Process:

1. Lead the database lock and unblinding process for the statistical team.
2. Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules).

Statistical Expertise:

1. 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).
2. Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data).
3. Provide expert review of ADaM reviewers guide (ADRG) and metadata.
4. Perform senior biostatistical review (SBR).
5. Produce or perform quality control review of sample size calculations for complex studies.

Requirements:

• Masters or PhD degree in Biostatistics or a related field and 10+ years' relevant experience within the life-science industry.
• 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.
• 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 pro-active problem-solving skills.
• Rare disease and immunology experience is greatly preferred.

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