Biostatistician - Health

Apple Inc.; Washington (District of Columbia); On-site; USD 158,000 - 238,000; Full time

Benefits offered by this job

Medical & dental coverage

Retirement benefits

Employee stock purchase plan

Tuition reimbursement

Job summary

Apple Inc. in Washington DC is seeking a Biostatistician to lead the statistical strategy and execution for clinical studies end-to-end: design studies, defend analyses to regulators, and translate results for engineers, clinicians, and product teams. Collaborate with Clinical Scientists, Regulatory, and external investigators.

As the statistical DRI for clinical studies in Apple Health, you will ensure data integrity, build templates, and advance data strategy and analysis standards."

Qualifications

• PhD or Master’s degree in biostatistics, statistics, or related quantitative field.
• Experience authoring clinical study documents including SAPs and CSRs.
• Familiarity with frequentist and Bayesian methods and regulatory requirements.

Responsibilities

• Serve as statistical DRI for clinical validation studies across gates.
• Design studies and author SAPs and CSRs.
• Plan supplemental data collection for future work.
• Coordinate with Regulatory, Marketing, Product, and other teams.
• Safeguard data integrity, pre-spec analyses, and multiplicity control.
• Develop reusable templates and align with GCP standards.
• Communicate results through reports and regulatory submissions.

Skills

Statistical programming

Clinical study docs

GCP knowledge

Stakeholder communication

Bayesian methods

Education

PhD or Master’s in Biostatistics

Tools

R

Python

SAS

Job description

Washington DC, District of Columbia, United States Hardware

At Apple, we build technology that helps people understand their health and act on it. The Health & Fitness team designs and executes the clinical research behind features that reach hundreds of millions of people — atrial fibrillation detection, hypertension, sleep apnea, and the next generation of health sensing. We are looking for a Biostatistician who wants their statistical work to end up in someone's pocket rather than only in a journal. In this role, you own the statistical strategy and execution for studies end-to-end: you help shape the questions, help design the studies that can answer them, defend the analyses to regulators, and translate the results for engineers, clinicians, and product teams. You will work with engineering study leads, clinical scientists, regulatory affairs, and external principal investigators. This is a role for someone who is equally comfortable arguing about an endpoint definition with a cardiologist and about a data pipeline with an engineer. If you care about scientific integrity, and about doing rigorous work at a scale very few organizations can offer, we would like to hear from you.

Description

You will serve as the statistical DRI for clinical studies within Apple Health, partnering closely with engineering study leads and clinical scientists to take features from concept through clinical validation and submission. You are accountable for the statistical rigor of study design, analysis, and reporting, and for the integrity of the data that supports our health claims. You will also help build the durable processes — data strategy, study templates, analysis standards — that let the team move faster on every study that follows.

Responsibilities

• Serve as the statistical DRI for clinical validation studies, coordinating with Clinical Scientists through every project gate.
• Design studies and author the statistical components of Clinical Investigation Plans, Statistical Analysis Plans, and Clinical Study Reports.
• Plan supplemental data collection so that a single study can support future work — for example, layering additional sensor data collection into an in-flight study to enable a downstream feature.
• Coordinate with Regulatory, Marketing, Product, and other cross-functional stakeholders throughout project gates, ensuring statistical validity of claims and product messaging remains aligned and defensible.
• Safeguard scientific integrity throughout study execution including blinding, pre-specification of analyses, handling of missing data, and control of multiplicity.
• Develop a deep understanding of existing datasets to translate clinical questions into appropriate statistical assessments.
• Lead strategic initiatives that raise the team's baseline: reusable study/analysis templates and GCP-aligned statistical practice.
• Communicate results through internal and external study reports and associated regulatory submissions and review.

Minimum Qualifications

• PhD or Master's degree in biostatistics, statistics, biomedical engineering, epidemiology, public health, or a closely related quantitative field.
• Working proficiency in a statistical programming language such as R, Python, or SAS, including experience working with or building statistical infrastructure or standards (i.e. reproducible analysis pipelines, validated programs, or reusable analysis functions or templates).
• Demonstrated experience authoring clinical study documentation including statistical analysis plans and clinical study reports.
• Familiarity with strengths and limitations of frequentist and Bayesian methods, adaptive designs, or real-world evidence approaches.
• Practical knowledge of GCP and the regulatory framework governing clinical investigations of medical devices.
• Demonstrated ability to bridge discussions between engineering and clinical experts.

Preferred Qualifications

• Therapeutic expertise in cardiology, women's health, or neurology.
• Established track record designing and executing clinical trials.
• Experience with diagnostic accuracy and agreement studies: sensitivity and specificity, positive predictive value, ROC analysis, and reader adjudication designs.
• Experience analyzing wearable, sensor, or other high-frequency longitudinal data, including handling of intermittent measurement and informative missingness.
• Strong scientific communication record: peer-reviewed publications, regulatory documents, and presentations to clinical and executive audiences.
• Experience with decentralized, remote, or app-based studies operating at large participant scale.

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $157,700 and $237,600, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant.

At Apple, we believe accessibility is a fundamental human right. You’ll find that idea reflected in everything here — in our culture, our benefits and our digital tools. By welcoming as many perspectives as possible, we help you build a career where you feel like you belong.

Learn about accessibility in Apple’s workplace.

Learn about reasonable accommodations for job applicants.

Apple accepts applications to this posting on an ongoing basis.