Senior Director/Executive Director, Biostatistics

Nkarta, Inc.•South San Francisco, CA

9d•$300,000 - $360,000•Hybrid

About The Position

Nkarta is seeking a hands-on, player-coach biostatistics leader to guide statistical strategy for its NKX019 autoimmune program, from ongoing multi-indication Phase 1/2 studies through potential pivotal trials. Reporting to the VP, Program Management and Head of Clinical Trial Services, this person will be the company’s most senior statistical voice with health authorities, the Board, investigators, partners, and the scientific community. The position is embedded in cross-functional program teams and combines leadership with direct statistical work, including authoring and owning analysis plans, defining estimands, conducting analyses, and shaping protocols, regulatory interactions, and scientific presentations. The role requires deep expertise in composite and responder endpoints in rheumatic and autoimmune diseases, as well as sound judgment evaluating single-arm trials against external, registry-based, or historical comparators. The successful candidate will translate Phase 1/2 evidence into quantitative support for indication, dose, and development decisions; design potential pivotal studies; and lead interim, dose-escalation, and dose-decision analyses. They will also oversee statistical deliverables, contribute to regulatory submissions, guide CROs and vendors, and build Nkarta’s in-house analysis capability and Biostatistics standards. The leader will partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Translational Medicine, Program Management, and Data Management. They will communicate statistical considerations clearly to internal and external stakeholders, establish quality and documentation practices, and recruit and develop Biostatistics and statistical programming staff and consultants as the function grows. At the Executive Director level, the role may include broader leadership of Biometrics. The position is based in South San Francisco, California, with priority given to candidates able to work a hybrid schedule from that location. Travel may be required for health-authority meetings, conferences, vendor oversight, and other business needs.

Requirements

PhD in Biostatistics or Statistics.
At least 8 years of clinical-trial biostatistics experience in the biopharmaceutical industry; at least 10 years for consideration at Executive Director level, including several years leading programs as the responsible statistician.
Hands-on ability to perform statistical analyses, develop and implement statistical methodologies, independently conduct complex analyses, apply advanced methods, and translate statistical concepts into practical clinical-trial solutions.
Deep experience in rheumatic and autoimmune diseases, such as SLE, lupus nephritis, myositis, systemic sclerosis, or rheumatoid arthritis, with hands-on ownership of composite and responder endpoints; experience must extend beyond oncology.
Leadership of Phase 3 or pivotal study design, including sample-size and power justification, multiplicity strategy, and design or evaluation of single-arm studies with external, registry-based, or historical control arms.
Direct experience preparing for and participating in FDA meetings, including End-of-Phase 2 and Type B/C/D meetings, and authoring statistical content for briefing documents, information-request responses, and BLA or NDA planning.
Ability to direct statisticians, statistical programmers, consultants, and CRO biostatistics teams and ensure external deliverables meet specifications and quality standards.
Hands-on proficiency in SAS and/or R and mastery of CDISC SDTM/ADaM and regulatory submission standards.
Excellent written and verbal communication skills, with a record of effective cross-functional partnership and comfort presenting to executives, Boards, investigators, and regulators.

Nice To Haves

Biostatistics leadership for B cell-directed therapies in autoimmune disease from early development through late-stage design.
Statistical leadership in the development or validation of a new patient-reported outcome instrument for a late-stage program.
Experience in cell or gene therapy, dose-escalation designs, independent data monitoring committees, and CBER-regulated products.
Experience building analysis capabilities and standards in a small company or transitioning work from vendors to an in-house team.

Responsibilities

Lead biostatistics strategy for the NKX019 autoimmune program and serve as statistician of record across indications, studies, and health-authority interactions.
Author and own statistical analysis plans and amendments, estimand frameworks, analysis populations, and TFL specifications; conduct complex analyses and review and approve statistical deliverables.
Design potential pivotal studies, including power and sample-size justifications, success thresholds, multiplicity strategies, adaptive designs where appropriate, and single-arm designs with external, registry-based, or historical comparators.
Own endpoint and estimand strategy for composite and responder endpoints, including approaches to intercurrent events such as rescue therapy and discontinuation.
Translate Phase 1/2 data into quantitative support for indication, dose, and development decisions, and present conclusions to the executive team and Board.
Design and deliver interim, dose-escalation, dose-decision, and other frequent data-cut analyses for congresses, data monitoring committee reviews, and Board updates; safeguard iDSMB independence and verify traceability from database to output.
Define derivation rules and analysis conventions with Clinical Development and Clinical Data Management.
Lead statistical content for abstracts, manuscripts, Board materials, and regulatory documents, including Investigator’s Brochures, DSURs, and clinical study reports.
Provide statistical leadership for patient-reported outcome strategy, including new instruments where fit-for-purpose measures do not exist.
Develop and defend statistical positions in FDA and other health-authority interactions; author statistical sections of briefing documents and information-request responses; and represent Biostatistics in meetings.
Build toward future submissions, including integrated summaries, CDISC SDTM/ADaM standards, external-control justification, and inspection-ready documentation.
Build in-house capability to generate tables, figures, and listings, working with programmers on specifications, programming standards, double-programming/QC, and version control.
Direct and review CRO and vendor deliverables, including analysis datasets, TFLs, and DSMB outputs; direct consultant statisticians and programmers on scope, quality, timelines, and contracted hours.
Advise leadership on the appropriate mix of employees, consultants, and CRO support, and contribute to vendor selection and the biometrics operating model.
Work as an embedded member of cross-functional teams and communicate statistical concepts, trade-offs, and uncertainty clearly to physicians, executives, Board members, investigators, and regulators.
Establish Biostatistics standards, including SAP and TFL-shell templates, CDISC-aligned analysis dataset specifications, QC, and documentation practices.
Recruit, develop, and lead Biostatistics and statistical programming staff and consultants; take on broader Biometrics leadership at the Executive Director level.