Senior Director/Executive Director, Biostatistics

About Us

Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease.

Founded in 2015, Nkarta is on a mission to harness the body’s natural killer cells – the immune system’s first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings.

Nkarta’s engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand.

Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.

THE OPPORTUNITY

This is a hands-on, player-coach leadership role for a senior biostatistician who has spent a career designing, analyzing and defending clinical trials in rheumatic and autoimmune diseases. Reporting to the VP, Program Management and Head of Clinical Trial Services, the Senior Director / Executive Director, Biostatistics will lead the biostatistics strategy for the NKX019 autoimmune program—from ongoing multi-indication Phase 1/2 studies through potential pivotal trial design—and will be Nkarta’s most senior statistical voice with the FDA, the Board, investigators, partners and the scientific community.

Nkarta is a small, resource-lean company. This leader will be an embedded, working member of the cross-functional program team—alongside Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Translational Medicine and Program Management—authoring and owning statistical analysis plans, defining estimands, performing analyses and driving the statistical content of protocols, health-authority interactions and scientific presentations. The right candidate is energized by rolling up their sleeves and doing the statistical work alongside the team.

The role calls for deep fluency in the composite and responder endpoints that define success in myositis, scleroderma, rheumatoid arthritis, lupus and related indications, and practical judgment in evaluating single-arm designs against external, registry-based or historical comparators. For the right candidate, it carries Executive Director scope and the opportunity to shape how Biometrics is built at Nkarta.

WHAT YOU’LL DO

Biostatistics Strategy & Hands-On Analysis

Lead the biostatistics strategy for the NKX019 autoimmune program and serve as statistician of record across all indications, studies and health-authority interactions.

Do the statistical work as lead statistician: author and own statistical analysis plans (SAPs) and amendments, estimand frameworks, analysis populations and TFL specifications; independently perform complex analyses; and review and sign off on every statistical deliverable that leaves the company.

Design potential pivotal studies, including power and sample-size justification, success thresholds, multiplicity strategy, adaptive designs where appropriate, and single-arm designs with external, registry-based or historical comparators and the sensitivity analyses regulators will expect.

Own endpoint and estimand strategy for composite and responder endpoints (for example revised CRISS, Total Improvement Score, mRSS, FVC, CDASI, SLE and lupus nephritis response criteria), including intercurrent events such as rescue therapy and discontinuation.

Translate the evolving Phase 1/2 dataset into the quantitative case for indication, dose and development decisions, and present it clearly to the executive team and Board.

Ongoing Clinical Studies & Analysis

Design and deliver interim, dose-escalation and dose-decision analyses and frequent data cuts for congresses, data monitoring committee reviews and Board updates; safeguard iDSMB independence and verify that results are traceable from database to output.

Define derivation rules and analysis conventions jointly with Clinical Development and Clinical Data Management so that response assessments, analysis populations and safety windows are specified once and applied consistently.

Lead the statistical content of abstracts, manuscripts, Board materials and regulatory documents (Investigator’s Brochure, DSURs, clinical study reports), and provide statistical leadership to patient-reported outcome strategy, including new PRO instruments where fit-for-purpose measures do not yet exist.

Regulatory Interactions & Submissions

Develop and defend Nkarta’s statistical positions in FDA and other health-authority interactions (Type B/C/D, End-of-Phase 2), author the statistical sections of briefing documents and information-request responses, and represent Biostatistics in the meetings.

Build toward future submissions: integrated summaries, CDISC SDTM/ADaM data standards, external-control justification and inspection-ready documentation.

In-House Analysis Delivery & Vendor Oversight

Build in-house capability to generate tables, figures and listings for conferences, health-authority meetings and Board materials, working with statistical programmers on specifications, programming standards, double-programming/QC and version control.

Provide technical direction, specification and acceptance review for CRO and vendor deliverables (analysis datasets, TFLs, DSMB outputs), and direct consultant statisticians and programmers against scope, quality, timeline and contracted hours.

Advise leadership on the right mix of employees, consultants and CRO support, and contribute to vendor selection and the biometrics operating model as the program advances toward potential pivotal studies.

Cross-Functional Partnership & Communication

Work as an embedded member of the cross-disciplinary program team—Clinical Development, Medical Affairs, Regulatory, Translational Medicine, Clinical Operations, Program Management and Data Management—and be sought out early, when designs and decisions are still open.

Communicate statistical concepts, trade-offs and uncertainty clearly to physicians, executives, the Board and investigators, without loss of rigor.

Standards, Quality & People Leadership

Establish Biostatistics standards (SAP and TFL-shell templates, CDISC-aligned analysis dataset specifications, QC and documentation practices) and stay current on guidance and methodology for autoimmune disease, externally controlled trials, estimands and cell therapy.

Recruit, develop and lead Biostatistics and statistical programming staff and consultants as the function grows; at Executive Director level, take on broader leadership of Biometrics.

WHAT WE’RE LOOKING FOR

Required

PhD in Biostatistics or Statistics and 8+ years of clinical-trial biostatistics experience in the biopharmaceutical industry (10+ years for consideration at Executive Director level), including several years leading programs as the responsible statistician.

Demonstrated hands-on proficiency in performing statistical analyses and in developing and implementing statistical methodologies; able to independently conduct complex analyses, apply advanced statistical methods and translate statistical concepts into practical solutions that support clinical trial design, analysis and interpretation.

Deep experience in rheumatic and autoimmune diseases (for example SLE, lupus nephritis, myositis, systemic sclerosis or rheumatoid arthritis), w