Associate Director, Biostatistics

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 DescriptionRole SummaryAs a key member of the Global Biometrics Department, theAssociate 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 ResponsibilitiesProvide 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 resultsPlan 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 toolsPartner 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 reportsIn partnership with other Biometrics members, interact with regulatory authority, other external bodies or scientific community on clinical trial statistical issuesProvide 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-makingResponsible for the statistical aspect of regulatory documents such as CSRs, as well as integrated reports and summary documentsCollaborate in departmental process improvement initiatives and development/revision of quality documentsMonitor changes in regulatory or, as needed, HTA requirements, industry standards, and company policies; update internal practices as needed to remain in complianceContribute 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 ProfileEducation and Required SkillsPh.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 techniquesInnovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle managementProficiency in SAS is strongly preferredAbility to determine appropriate designs and analyses for clinical trialsand/or evidence generationStrong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs as neededMust have a working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendicesMust have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA)and industry standardsapplicable toclinical development orevidence generationDirect regulatory filing experience is preferredfor roles supporting clinical developmentAbility to respond to regulators or other external inquiriesAbility to take appropriate action in all dealings with CRO partners to ensure best practices are followedDemonstrated sound judgment and decision-making, with the ability to evaluate business impact, follow through on decisions, and adapt as priorities changeTravel and LocationSome domestic and international travel requiredOn-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to BostonServier’s CommitmentServier 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 RangeThe 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.