Job Description

Role Summary

As a key member of the Global Biometrics Department, the Associate Director, Biostatistics will work on one or more assets or indications, contributing to all statistical aspects of the clinical development plan, individual studies, submissions, or evidence generation activities. This role partners closely with clinical, regulatory and other evidence generation stakeholders to provide quality, regulatory relevance, and scientific validity.

Primary Responsibilities

• Provide statistical support on one or more assets or indications by directing the execution of statistical analyses, review of statistical outputs, and ensuring accurate results interpretation, collaborating closely with physicians, evidence generation stakeholders, or other cross-functional leads as appropriate on the interpretation of clinical results
• Plan and track activities and timelines across projects; justify resource needs and ensure efficient utilization of available capacity
• Provide input into product development, medical affairs or HEOR/HTA strategy by suggesting innovative designs and decision-making tools
• Partner with other Biostatistics department members or consultants, to develop effective statistical approaches applicable to project.
• Select appropriate statistical methods for study design and data analysis, review protocols and statistical methods and results sections for study reports
• In partnership with other Biometrics members, interact with regulatory authority, other external bodies or scientific community on clinical trial statistical issues
• Provide guidance to the clinical, regulatory, and/or evidence generation teams on conclusions and inferences from the data package, ensuring statistical perspective is integrated into regulatory and external meetings, and delivering data packages aligned with submission requirements or key decision-making
• Responsible for the statistical aspect of regulatory documents such as CSRs, as well as integrated reports and summary documents

• Collaborate in departmental process improvement initiatives and development/revision of quality documents
• Monitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in compliance
• Contribute to publication plan by reviewing abstracts, posters, and manuscripts to support Medical Affairs.
• Contribute to the establishment and maintenance of common formats and templates for key Biostatistics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings)

Candidate Profile

Education and Required Skills

• Ph.D. in Biostatistics or closely related field is required with a minimum of 5 years of relevant pharmaceutical experience. Master's degree in Statistics or related field may be considered with minimum of 8 years of experience.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques
• Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
• Proficiency in SAS is strongly preferred
• Ability to determine appropriate designs and analyses for clinical trials and/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
• Must have a working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices
• Must have a 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
• Direct regulatory filing experience is preferred for roles supporting clinical development
• Ability to respond to regulators or other external inquiries
• Ability to take appropriate action in all dealings with CRO partners to ensure best practices are followed
• Demonstrated sound judgment and decision-making, with the ability to evaluate business impact, follow through on decisions, and adapt as priorities change

Travel and Location

• Some domestic and international travel required
• On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston

Salary Range

The salary range for this role is $164,000-194,000. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.