Director, Biostatistics

SERVIER MONDE•Boston, MA

5d•$204,000 - $246,000•Hybrid

About The Position

As a strategic leader within the Global Biometrics Department, the Director, Biostatistics leads the development and implementation of statistical solutions in clinical trials, evidence generation, and decision making. This role will lead the statistical strategy for assigned clinical development products or evidence generation across our portfolio and may supervise statisticians both in-house and at CROs, ensuring timely and high-quality biostatistics deliverables. In addition, this individual may independently represent Biostatistics in interactions with regulatory authorities or the external scientific community.

Requirements

Ph.D. in Biostatistics or closely related field is required with a minimum of 9 years of relevant pharmaceutical experience. Master’s degree in Biostatistics or related field may be considered with a minimum of 12 years of relevant pharmaceutical experience
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Ability to determine appropriate designs and analyses for clinical trials or evidence generation.
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs as needed.
Working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices.
Working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA) and industry standards applicable to clinical development or evidence generation
Ability to respond to regulator or other external body’s inquiries
Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed
Proficiency in SAS is strongly preferred

Nice To Haves

Direct regulatory filing experience is preferred for roles supporting clinical development

Responsibilities

Act as the biostatistics expert and leader, serve as primary statistical representative for cross-functional teams, including clinical, evidence generation, and asset teams, and communicate plans and strategy to subordinates
Lead a small team of Biostatisticians, supporting talent acquisition, career development, retention, and resourcing needs in partnership with department leadership, mentor junior biostatisticians in project teams
Provide strategic statistical leadership and oversight for multiple assets or indications. Accountable for the quality and timeline of statistical deliverables, including design, analyses, and interpretation of results.
Advocate for resource allocation and ensure efficient utilization of available capacity, optimizing project outcomes and enhancing operational efficiency
Propose and advocate for innovative designs and decision-making tools for product development or other evidence generation strategies
Lead the evaluation and adoption of appropriate statistical methodologies for design and analysis to optimize study efficiency and increase the probability of technical success.
Proactively identify potential statistical risks and develop robust contingency plans to ensure integrity and meeting project milestones.
Influence and lead departmental process improvement initiatives and the development and revision of quality documents
Responsible for interacting with regulatory authorities, other external bodies or scientific community on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Responsible for the statistical aspects of regulatory documents such as protocols, investigator brochures, study reports, and submission packages as well as integrated reports and summary documents
Oversee the publication strategy by reviewing and approving abstracts, posters, and manuscripts
Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance
Develop and standardize key Biostatistics documentation (e.g., statistical sections of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings)