Director, RWE Scientist

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $196k - $245k / year

⏰ Full Time

🔴 Lead

👔 Director

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 Description

• Design and execute real-world studies for the atumelnant program (CAH adult, CAH pediatric, Cushing's disease) • Own and steward Crinetics' CAH real-world data assets—ensuring continuity, documentation, and reusability of cohorts, code lists, and analytic datasets • Lead analyses using large healthcare databases (insurance claims, EHRs, registries, linked datasets) and primary RWD collection (chart reviews, surveys) • Develop study protocols, statistical analysis plans, and feasibility assessments; perform database selection and confirm that patient counts and study variables exist in available data • Ensure continuity of atumelnant RWE through launch, maintaining institutional knowledge of CAH RWE assets and program evidence needs • Translate evidence priorities set by HEOR/RWE TA Leads, under direction from the RWE COE Head, into executable analyses tied to launch and lifecycle milestones • Apply rigorous epidemiologic and outcomes-research methods, including appropriate causal-inference and bias-control techniques for observational data • Lead and mentor external analysts supporting in-house RWE analytics projects—scoping the work, directing analyses, and reviewing deliverables for methodological quality • Oversee RWE study vendors when analyses are outsourced—managing CRO/data-vendor execution against scope, timelines, budget, and deliverable quality • Contribute RWE outputs to integrated evidence plans, value dossiers, and HTA submissions in partnership with TA Leads and cross-functional stakeholders • Collaborate with the RWE Center of Excellence, Modeling & Simulation, Biometrics, and external data and analytics partners on study design and execution • Prepare manuscripts, abstracts, and congress presentations communicating RWE findings • Ensure compliance with corporate policies and US healthcare laws and regulations governing real-world data use • Other duties as assigned.

🎯 Requirements

• Advanced degree in epidemiology, biostatistics, health services research, health economics, or related discipline (PhD, MD, PharmD, MPH, MSc) • Minimum of 10 years of relevant pharmaceutical, biotech, or HEOR consulting experience executing observational research • Proven experience leading and developing teams, including external analysts or vendor partners • Demonstrated expertise designing and executing observational studies using large real-world datasets (claims, EHR, registries) • Strong working knowledge of real-world data programming and analytics (R preferred; SQL, SAS, or Python also valued) • Knowledge of epidemiologic and outcomes-research methodologies, including causal-inference and bias-control techniques for observational data • Experience with feasibility assessment, database selection, and study-design strategies to address real-world data limitations • Experience overseeing external analysts and/or CRO/data vendors, including scoping, oversight, budget management, and quality review of deliverables • Working knowledge of regulatory and HTA evidence expectations for RWE (FDA RWE Framework, ISPOR/ISPE good-practice guidance) • Strong written and verbal communication skills, including scientific publication and presentation • Ability to collaborate effectively across functions and with external data partners • Ensure compliance with corporate policies and procedures, as well as US healthcare laws and regulations • Flexible, adaptable, and able to operate effectively in ambiguity; detail-oriented with strong execution discipline.

🏖️ Benefits

• discretionary annual target bonus • stock options • ESPP • 401k match • health insurance plans for employees (and their families) to include medical, dental, vision, and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown