Biostatistician Health

At Apple we build technology that helps people understand their health and act on it. The Health u0026 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 are looking for a Biostatistician who wants their statistical work to end up in someones pocket rather than only in a 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 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.n

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.

Serve as the statistical DRI for clinical validation studies coordinating with Clinical Scientists through every project studies and author the statistical components of Clinical Investigation Plans Statistical Analysis Plans and Clinical Study 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 with Regulatory Marketing Product and other cross-functional stakeholders throughout project gates ensuring statistical validity of claims and product messaging remains aligned and scientific integrity throughout study execution including blinding pre-specification of analyses handling of missing data and control of a deep understanding of existing datasets to translate clinical questions into appropriate statistical assessments. nLead strategic initiatives that raise the teams baseline: reusable study/analysis templates and GCP-aligned statistical results through internal and external study reports and associated regulatory submissions and review.n

PhD or Masters degree in biostatistics statistics biomedical engineering epidemiology public health or a closely related quantitative 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).nDemonstrated experience authoring clinical study documentation including statistical analysis plans and clinical study with strengths and limitations of frequentist and Bayesian methods adaptive designs or real-world evidence knowledge of GCP and the regulatory framework governing clinical investigations of medical ability to bridge discussions between engineering and clinical experts.

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

Required Experience:

IC

Employment Type : Full Time
Experience: years
Vacancy: 1