Senior Director/Executive Director, Biostatistics

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), with hands-on ownership of composite and responder endpoints such as SRI-4, BICLA, ACR20/50/70, Total Improvement Score or rCRISS-type measures; experience must extend beyond oncology.
• Demonstrated leadership of Phase 3 or pivotal study design, including sample-size and power justification, multiplicity strategy and the design or evaluation of single-arm studies with external, registry-based or historical control arms.
• Direct experience preparing for and participating in FDA meetings (End-of-Phase 2, Type B/C/D) and authoring statistical content for briefing documents, information-request responses and BLA or NDA planning.
• Proven ability to direct statisticians, statistical programmers, consultants and CRO biostatistics teams, and to hold external deliverables to specification and quality.
• Hands-on proficiency in SAS and/or R and mastery of CDISC SDTM/ADaM and regulatory submission standards.
• Excellent written and verbal communication skills and a track record as a trusted, embedded member of cross-functional teams; comfortable presenting to executives, Boards, investigators and regulators.

Preferred

• 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 capability and standards in a small company, or in moving work from vendors to an in-house team.

LOCATION & WORK ENVIRONMENT

Priority will be given to candidates who can work a hybrid schedule and based in South San Francisco, CA. Travel may be required for health-authority meetings, conferences, vendor oversight, and other business needs.