Director, Biostatistics (Boston, MA, US)

About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision.

Job Description

Role Summary

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.

Primary Responsibilities

 

Strategic Ownership & Leadership

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

 

Regulatory & Scientific Accountability

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)

Candidate Profile

Education and Required Skills

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

Direct regulatory filing experience is preferred for roles supporting clinical development

Proficiency in SAS is strongly preferred

 

Travel and Location

Some domestic and international travel required

Onsite in Boston (2-3 days hybrid) or 100% remote with occasional travel to Boston

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $204,000-$246,000. 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 .

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