[Remote] Director Biostatistics, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. AskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines. The Director, Biostatistics, will provide technical leadership and operational oversight for clinical strategies, collaborating with cross-functional teams and ensuring high quality deliverables in biostatistics for drug development.ResponsibilitiesResponsible for all deliverables related to statistical content. Provides guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverablesAdvises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impactOversees the biostatistics function in CRO’s; manages scope of work and relationships with other external statistician consultants as neededManages resources, sets priorities, and ensures consistency and adherence to standardsCollaborates on protocol development including study design, endpoint selection, and power and sample size assessmentResponsible for SAP, data analysis and reporting (CSR). Supports DMC charter and meeting preparationRepresent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health AuthoritiesSupports regulatory submission and interaction, i.e, and IND/BLA filings and supports potential partnering requestsBecomes an integral member of cross-functional project teams, provides statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentationsDevelops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionallyContributes to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization effortsMaintains currency of new developments in statistics, drug development, and regulatory guidanceParticipates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as neededAssists with the Business Development activities at key conferences and industry meetingsSupports scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion LeadersPresents at industry conferences representing AskBioParticipates in vendor evaluation, selection, and managementSkillsPh.D. or M.S. in Statistics or related field10+ years pharmaceutical experience in a pharmaceutical R&D environmentKnowledge of Heart Failure and Cardiovascular programsStrong knowledge of design of experiments, clinical trial design concepts, or CMC statistics, drug regulation, and experience in the management of the statistical functionExperience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy preferredExtensive experience with SAS and/or RExcellent communication skillsExperience in CRO selection, contracting and managementExcellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the CompanyExperience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapyEducation RequirementsPh.D. or M.S. in Statistics or related field.Company OverviewAskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. It was founded in 2001, and is headquartered in Chapel Hill, North Carolina, USA, with a workforce of 501-1000 employees. Its website is http://www.askbio.com/.Company H1B SponsorshipAskBio Inc. has a track record of offering H1B sponsorships, with 1 in 2024, 4 in 2023, 8 in 2022, 3 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.