Praxis Precision Medicines, Inc.

Support development and validation of analytical pipelines and statistical models in R/Python, ensuring regulatory compliance and automation. | 5+ years in statistical programming within pharma/biotech, experience with R/Python, regulatory submission support, knowledge of CDISC standards, and familiarity with CI/CD pipelines. | Location: This position may be performed remotely but requires flexibility and a willingness to travel as needed. Position Summary Praxis is seeking a Senior Statistical Data Scientist to support the development, validation and automation of analytical pipelines and statistical models that support metadata-driven clinical data processing, reporting, and regulatory submissions. This hands-on, technical role is ideal for a data scientist or statistical programmer who enjoys coding, problem-solving, and working cross-functionally to bring rigor, reproducibility, and automation to clinical reporting workflows. The Senior Statistical Data Scientist will contribute directly to R/Python development while also setting technical standards, mentoring peers, and ensuring readiness for R-based regulatory submissions. Primary Responsibilities Support 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 5+ 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! Annualized Base Salary $150,000—$168,000 USD 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 careers@praxismedicines.com. 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.

Plan and execute CMC regulatory strategies, manage regulatory submissions, collaborate with cross-functional teams, and lead responses to health authority inquiries. | Minimum 8 years industry experience with 5 years in regulatory affairs focused on CMC, scientific degree, deep knowledge of FDA and global regulations, and strong communication and leadership skills. | Senior Manager, CMC Regulatory Affairs Location: This position has the ability to work remotely with regular travel to the Boston area as needed. Position Summary The Senior Manager, CMC Regulatory Affairs will be responsible for planning and executing the CMC regulatory strategies for assigned development programs. You will partner with CMC technical leads, Quality Assurance, and other technical areas to develop optimized plans for successful regulatory submissions. Primary Responsibilities Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals Align CMC regulatory plans with cross-functional development and manufacturing teams Execute regulatory strategies: track and manage progress within defined timelines Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates Independently and in collaboration with CMC team members, write Module 3 sections to support INDs, IMPDs, NDAs and MAAs. Critically evaluate health authority questions and lead the team of cross-functional SMEs to write responses. In collaboration with CMC team members, write questions and briefing documents in support of Health Authority meetings such as Type C meetings with FDA, and Scientific Advice meetings with EMA. Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes Facilitate the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments Disseminate global CMC regulations and guidelines with appropriate interpretation Education and Professional Preferred Experience Minimum of BS or BA in a scientific or technical discipline, advanced degree preferred. Equivalent combination of education and applicable job experience may be considered Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC responsibilities Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including US FDA and international regulatory requirements (EMA, ICH, Health Canada, LATAM and others), guidance, accelerated regulatory review paths, and policy trends, with expertise in small molecule and oligonucleotide-based product development preferred Proven track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company Experience with Veeva Vault is a plus Other Essentials and Key Success Factors Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, and program recommendations. Persistent but polite/respectful in proactively driving change, and able to deal with a diverse group of people with different strengths, skills, and methods of interacting with others while gaining their support. Team player willing to roll up their sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Self-motivated, comfortable with independently making decisions and communicating in a direct fashion, able to contribute to a productive and collaborative team environment Highly organized and detail-oriented with a passion to deliver quality results Strong verbal and written communication skills Approaches his/her work with professionalism, integrity and personal confidence 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! Annualized Base Salary $110,000—$130,000 USD 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 careers@praxismedicines.com. 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.

Oversee and manage stability studies and analytical testing programs in collaboration with CDMOs ensuring compliance with regulatory guidelines and supporting product development. | Bachelor's degree in Analytical Chemistry or related field with 7+ years in GMP-regulated pharmaceutical environment and hands-on experience with stability and reference standard programs. | Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity We are seeking a Manager/Senior Manager to support and strengthen our growing CMC team. The ideal candidate will leverage previous laboratory-based experience to provide operational oversight of analytical testing and stability programs in collaboration with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug substance and drug product services to the pharmaceutical industry. This role is critical to ensure that the Praxis analytical testing network is robust and operates at peak performance. In addition, you will be responsible for overseeing the execution and lifecycle management (planning, set-up, and execution) of stability studies across Praxis' development portfolio, ensuring compliance with ICH guidelines and regulatory expectations. The role requires close coordination with CDMOs, internal Analytical Development, Drug Substance and Drug Product teams, CMC Outsourcing, Quality Assurance, Regulatory CMC, and Manufacturing functions to ensure timely generation and interpretation of analytical testing and stability data that support product shelf-life, storage, and regulatory submissions. Primary Responsibilities • Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines. • Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis' document management system. • Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information. • Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team. • Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases, ensuring alignment with regulatory and project timelines. • Monitoring CDMO performance with respect to agreed timelines for providing stability protocols and reports and establishing metrics, as needed • Review of raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads. • Perform trend analysis of stability data to be used in shelf-life assessment. • Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies. • Monitor the execution of our reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites. Qualifications and Key Success Factors • Bachelor's degree in Analytical Chemistry or a related discipline with at least 7 years of relevant industry experience in a GMP-regulated environment; advanced degree a plus but not required. • Hands-on experience supporting stability and reference standard programs for small molecule drug substances and oral drug products (e.g., tablets, capsules, suspensions), including sample tracking, data trending, and documentation. • Strong, working knowledge of stability study tracking software, such as Smartsheet, to monitor stability studies and evaluate CDMO performance. • Working knowledge of US and EU cGMP requirements, ICH guidelines and compendial standards (e.g., USP, EP) applicable to stability studies and reference standards. • Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the company's objectives are achieved. • Strong communication skills and the ability to work effectively with cross-functional teams including Analytical Development, Quality Assurance, and Regulatory Affairs. • Ability to support investigations and trending activities, including compilation of stability data tables, graphs, and summaries for internal and regulatory use. • Strong attention to detail along with the ability to perform meticulous data review and data transcription review. • Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. • 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. Annualized Base Salary $145,000-$175,000 USD 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 careers@praxismedicines.com. 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.