Director, Real World Evidence (RWE) Statistical Lead

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

Role Summary

The Real World Evidence (RWE) statistical lead is an integral member of the global biometrics team, who leverages expertise in real world data analysis to develop fit-for-purpose RWE strategy. This position interacts with collaborators to provide a strong statistical and scientific expertise from the strategic mindset in the project and deliverables. This position is also expected to provide an excellent communication to provide an input in the use of real-world evidence (RWE) from the broader view in the entire value chain.   

Primary Responsibilities

• Lead and mentor a team of RWE statisticians
• Provide expertise in the conception and design of Real-World Evidence studies, providing expert statistical support including data feasibility, study design, statistical section of the protocol, development of the statistical analysis plan and interpretation of the results.
• Provide programming expertise to generate statistical programming deliverables.
• Oversee the review of statistical documents within the team and supervise operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements.
• Develop, implement, and promote new methodology and innovative analytics method (e.g. External Control Arm, machine learning, predictive model…).
• Lead or contribute to departmental process improvement initiatives and development of standards for RWE.
• Contribute to the RWE strategy to support regulatory agency interactions.
• Develop effective collaborations with relevant stakeholders including RWE leads, and scientists, clinicians, RWE statisticians, and statistical programmers regarding RWD analysis and strategy.
• Plan and track project activities, timelines, across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation

Education and Required Skills

• M.S. in Biostatistics or closely related field
• Ph.D. in Biostatistics or closely related field is strongly preferred.
• At least 8 years of relevant experience within biopharma companies, RWE consulting firms, or other relevant healthcare industries
• Excellent understanding of statistical methodologies, real-world data, and observational studies.
• Experience on statistical software (e.g. SAS, R, Python) and secondary data sources including registries, EMR and claims is an advantage.
• Extensive hands-on experience with data extraction, cleaning, and analysis, as well as statistical methods to mitigate confounding and selection biases
• Expertise in drug development
• Ability to determine appropriate designs and analyses for RWE studies.
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
• 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)
• Excellent interpersonal, communication and presentation skills

Travel and Location

• Some domestic and international travel required
• Boston hybrid preferred with 2-3 days/week in office.

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.