Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
Praxis is seeking an Associate Director, Statistical Data Scientist to lead and execute the development, validation and automation of analytical pipelines and statistical models that support metadata-driven clinical data processing, reporting, and regulatory submissions. This is a hands-on technical leadership role, ideal for a senior data scientist or statistical programmer who enjoys coding, problem-solving, and working cross-functionally to bring rigor, reproducibility, and automation to clinical reporting workflows. You will contribute directly to R/Python development while also setting technical standards, mentoring peers, and ensuring readiness for R-based regulatory submissions.
Primary Responsibilities
- Lead the design, development, and validation of R/Python code to automate generation of analytical datasets and TLFs within a metadata-driven pipeline.
- Translate SAPs and metadata specifications (YAML/CSV) into executable and reproducible code.
- Build and validate R packages and data science tools supporting both exploratory and confirmatory analyses, ensuring full traceability and audit readiness.
- Implement and validate statistical models (e.g., MMRM, ANCOVA, logistic regression) using R packages such as mmrm, emmeans.
- Collaborate with IT to integrate data science and statistical programming workflows within Databricks and CI/CD pipelines for continuous validation and reproducibility.
- Collaborate across programming, biostatistics, and data standards functions to ensure dataset definitions, derivations, and metadata align with controlled standards.
- Conduct peer code reviews, unit testing, and automated validation; ensuring deliverables meet submission-quality and reproducibility standards.
- Mentor and guide team members in best practices for programming, validation, and automation.
Qualifications and Key Success Factors
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Data Science, or a related field with 8+ years of statistical programming experience in the pharmaceutical/biotech industry including hands-on experience with R and/or Python.
- Proven experience preparing or supporting R-based regulatory submissions (e.g., R package validation, R-based analysis delivery, or submission readiness).
- Strong understanding of CDISC ADaM and SDTM data structures, and their use in analytical workflows.
- Experience developing and validating reusable R/Python libraries and functions.
- Proficiency with Git, Bitbucket, and CI/CD automation pipelines.
- Working knowledge of GxP and Part 11 compliance.
- Preferred familiarity with YAML/JSON configuration and metadata-driven programming workflows.
- Prior experience migrating from SAS to R/Python environments.
- Knowledge of R validation frameworks (e.g., risk-based testing, reproducibility documentation).
- Experience with exploratory analytics or visualization in R or Python within a regulated framework strongly preferred.
- Excellent documentation and validation practices.
- Collaborative and proactive mindset; able to operate independently in a small, agile team.
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Compensation & Benefits
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected].
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Top Skills
Praxis Precision Medicines, Inc. Boston, Massachusetts, USA Office
99 High St, Boston, MA , United States, 02110
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