Director of Biostatistics

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team : Competitive compensation for your workGenerous time off policySummer FridaysOpportunity to broaden your horizons by attending popular conferencesEmphasis on work / life balanceCollaborative and team-oriented environmentMaking a positive impact to help ultra-rare disease patients who are in need of life-saving treatmentsJob Description The Statistical Science Director provides highly experienced statistical, scientific and strategic support to the clinical and regulatory strategies across all phases of drug development, in-licensing opportunities, pre-clinical development, marketing activities, and other specialized areas and / or line functions (e.g. drug safety, clinical pharmacology) to maximize the benefit-risk of Sobi products.The Statistical Science Director typically takes on the role of Product Statistician.The Product Statistician : is accountable for the overall quality and timely delivery of statistical analyses for the assigned productsis accountable for all statistical aspects within assigned products, providing statistical, scientific, and strategic expertise to quantify the benefit-risk value and uncertainty of the emerging product profile throughout all phases of the drug development process in compliance with Sobi SOPs and regulatory requirements / guidelines.is accountable for leading the statistical thinking and contributions to the creation and development of TPP / TPC, Target Label, and Clinical Development Plans, as well as to the Regulatory and Commercial Strategies for Sobi products.provides leadership and project coordination to all statisticians working on the project, including in-house consultants and statisticians at CROsis accountable for the statistical content in the CSP and CSRThe Statistical Science Director is qualified for membership in the Study Document Review Forum (SDRF) and may also participate in in-licensing projects or work in other roles as appropriate.The Statistical Science Director is responsible for coaching and developing less experienced statisticians.Provide leadership and project coordination to all statisticians working on the project, including in-house consultants and statisticians at CROsProvide statistical and strategic input into the establishment of a focused, aligned, and achievable Target Product Profile (TPP) and Target LabelsProvide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP), ensuring alignment with the TPPs and Target LabelProvide statistical and strategic input to relevant documents in regulatory submissions, e.g. eCTDTake a proactive role in designing innovative studies and programs, including Go / No Go criterion and associated risk levels, to meet project objectives and regulatory requirementsApprove and sign CSPs, including the statistical contentApprove Statistical Analysis Plans for studies and regulatory submissionsApprove and sign CSRs, including the statistical analysis and clinical interpretation of study dataParticipate in preparing responses to regulatory questionsProvide statistical and strategic input into other regulatory documentation, e.g. CSP, CSR, IB, PSUR, and RMPParticipate in developing the publication strategy as a member of the publication teamContribute to the writing of publications and abstracts, in accordance with the publication strategy for the project, as applicableEnsure high-quality statistical support for projects through the evaluation of CRO suppliers and provide input into outsourcing strategy and processesCollaborate with internal statisticians to drive best practices and implement new initiativesStay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.Contribute to the development of SOPs as relevantParticipate in the review and approval of study essential documents in the role as a project-independent statisticianQualifications Education / Learning ExperienceRequired : Bachelor of Science (BSc) in mathematical statistics, statistics, or equivalent.Desired : Master of Science (MSc) or PhD in mathematical statistics, statistics, or equivalent.Work ExperienceRequired : 8 years of experience as a statistician in the pharmaceutical industryPrevious leadership experience from project and / or line managementExtensive experience working in phase II, III, and IV programs and / or studiesExtensive experience of clinical program and study design and data analysis using a variety of designs and complex statistical techniques, with different types of data and issuesExperience of major regulatory submissions and / or previous attendance at meetings with regulatory authoritiesExperience working in all phases of clinical developmentExtensive experience of regulatory submissions and previous attendance at meetings with regulatory authorities in more than one region, e.g. Europe, US, Japan, and ChinaExperience of collaboration with statisticians and other functions at CROs around outsourced clinical studiesSkills / KnowledgeRequired : Comprehensive knowledge of clinical and pharmaceutical drug developmentSound knowledge of theoretical and applied statisticsAbility to find innovative approaches to trial design and analysisSound understanding of the regulatory environment within clinical developmentAbility to be the statistical representative from the company at regulatory interactionsAbility to coach less experienced statisticians in all aspects of their role.Personal AttributesRequired : Excellent written and oral communication skillsStrategic thinking and influencing skillsAbility to communicate statistical information to non-statisticiansStrong ability to collaborate and contribute in global cross-functional teamsLanguagesRequired : Excellent writing and oral communication in EnglishAdditional Information All Sobi employees need to demonstrate behaviors in line with Sobi's core values : Care, Ambition, Urgency, Ownership, and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.Why Join Us?We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments, and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.Sobi CultureAt Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into groundbreaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners, and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.An Equal Opportunity EmployerSobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and / or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.Sobi is an affirmative action and equal opportunity employer. Disabled / Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.comCOVID-19 PolicyFor the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.#J-18808-Ljbffr