Senior Director, Biostatistics Position Available In Middlesex, Massachusetts

Job Description:

Why Join Intellia? Our mission is to develop curative genomeediting treatments that can positively transform the lives ofpeople living with severe and life-threatening diseases. Beyond ourscience, we live our four core values: One, Explore, Disrupt,Deliver and feel strongly that you can achieve more at Intellia. Wehave a single-minded determination to excel and succeed together.

We believe in the power of curiosity and pushing boundaries. Wewelcome challenging thoughts and imagination to develop innovativesolutions. And we know that patients are counting on us to make thepromise a reality, so we must maintain high standards and get itdone. We wantall ofour people to go beyond what is possible. Wearen’t constrained by typical end rails, and we aren’t out to just”treat” people. We’re all in this for something more. We’re drivento cure and motivated for change. Just imagine the possibilities ofwhat we can do together. Senior Director, Biostatistics Job SummaryThe Senior Director of Biostatistics is responsible for leading thestatistical activities for 1 or more clinical programs, providingstrategic input on clinical development, leading statistics effortsduring regulatory submissions, serving as the primary statisticspoint person in interactions with health authorities, andleveraging their experience to provide general input and feedbackon programs in the pipeline. Duties/Responsibilities Providesleadership and guidance as the statistical expert on clinicalprogram teams while being accountable for all statistical aspectsof clinical studies and regulatory submissions. Provides input andfeedback to other programs when needed based on their experience.

Leads statistical discussions with external parties includingHealth Authorities and co-development partners. Provides strategicinput into program documents such as clinical development plans andtarget product profiles. Ensures study designs are valid,efficient, and allow for clearly interpretable results.

Authors/reviews study and program biostatistics documents (e.g.,clinical study protocols, statistical analysis plans (SAP), MockTables, Listings, and Figures shells). Designs TLFs forstudy-related analyses, posters, and presentations. Oversees theactivities of FSP and CRO biostatistics teams, ensuring adherenceto scope of work and service agreements and that deliverables aremet in accordance with study milestones/timelines and of acceptablequality. Ensures deliverables are completed in a timely deliveryand with high quality, including regulatory documents. Providesstatistical support to other organizations within company inaddition to Development. Leads complex process development efforts,creation of biometrics standards, and development of newmethodologies. Remains apprised of current/new developments andtechnological advancements in statistics. Mentors/coaches juniorstatisticians. Supervisory Responsibilities ? N/A Recruits,interviews, and trains new hires. Oversees the daily activities ofdirect reports and ensure accurate and timely deliverables areprovided. Provides constructive and timely performance evaluations.

Requirements Extensive experience in preparing and participating inglobal regulatory agency interactions, including NDA/BLA/MAAsubmissions. Proficiency in scientific computing/programming (SAS,R or Python) and implementation of advanced statistical analysis,data manipulation, graphing, and simulation. Ability to identifydata or analytical issues and assist with providing solutions byeither applying own skills and knowledge or consulting with subjectmatter experts. Expertise in clinical trial designs and studyconduct in all phases of development within relevant therapeuticareas. Expert in ICH GC and industry/regulatory trends andstandards. Ability to build strong relationships with peers andcross-functional partners to achieve higher performance. Strongproject management skills. Highly motivated to drive innovation byraising the bar and challenging the status quo. Demonstrateexcellent collaboration, organizational/ leadership abilities, andinterpersonal skills with the ability to clearly explainstatistical considerations to non-statisticians. PhD or MS inStatistics or related field At least 12 years of experience in thePharmaceutical/Biotechnology industry. Prolonged periods of sittingat a desk and working on a computer. Must be able to lift up to 15pounds at times. LI-Remote Covid-19

Vaccination Policy:

AllIntellia employees, regardless of work location, are expected tofollow all applicable federal, state, and local public healthregulations and guidelines, and are strongly encouraged to followall public health recommendations, including being vaccinated for

COVID-19. EEOC

Statement:

Intellia believes in a diverseenvironment, and is committed to equal employment opportunity forall its employees and qualified applicants. We do not discriminatein recruitment, hiring, training, promotion or any other employmentpractices for reasons of race, color, religion, gender, nationalorigin, age, sexual orientation, marital or veteran status,disability, or any other legally protected status. Intellia willmake reasonable accommodations for qualified individuals with knowndisabilities, in accordance with applicable law.