Encoded Therapeutics

Oversee and validate statistical programming activities supporting clinical studies, ensuring compliance with standards and regulatory requirements. | Requires 7+ years of experience in statistical programming within biotech or pharma, with expertise in SAS, CDISC standards, and CRO oversight. | Encoded Therapeutics is a biotechnology company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases. For more information, please visit www.Encoded.com. Reporting to the Director of Statistical Programming, the Senior Manager of Statistical Programming serves as internal technical programming owner and oversight lead for statistical programming activities supporting clinical studies within Encoded Dravet program. This role is responsible for independent validation, in-depth review, and quality oversight of CRO-produced statistical programming deliverables, including SDTM, ADaM, TFLs, and submission-related documentation. This is a hands-on, individual contributor role requiring strong technical expertise in CDISC standards, regulatory programming, and CRO oversight, combined with the ability to manage timelines, risks, and frequent study changes in a fast-paced, sponsor-led biotech environment. While the role does not initially include direct people management, it carries senior-level accountability for ensuring programming quality, consistency, and submission readiness across studies. Responsibilities: Lead and oversee statistical programming deliverables of clinical studies under Encoded Dravet program Perform independent validation and in-depth review of SDTM and ADaM datasets to ensure compliance with CDISC standards and study specifications, and regulatory requirements Review and validate tables, listings and figures (TLFs) supporting Clinical Study Reports (CSR), ISS and ISE Document validation findings and provide clear, actionable and timely review comments on CRO deliverables Support internal ad hoc analyses to address study questions, regulatory requests, or internal decision making Develop programming macros, templates and specifications to enable consistent, efficient programming practices across studies Collaborate closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, and Quality Assurance to align on analysis plans, submission strategy, and timelines Actively manage study timelines, risks, and analysis changes, proactively identifying issues related to programming activities and data quality Bachelor’s or Master’s degree in Biostatistics, Mathematics, Computer Science, or a related quantitative discipline, with 10+ (or 7+ years with a Master’s degree) of statistical programming experience in pharmaceutical, biotech or CRO environments Advanced SAS programming expertise in a clinical trial and regulatory setting; working knowledge of R, Python or other programming languages is a plus Demonstrated experience leading oversight, validation and in-depth review of CRO statistical programming deliverables Strong working knowledge of CDISC standards in SDTM, ADaM dataset structures, complex derivations, and traceability Experience contributing to or developing departmental programming tools such as macro libraries, specification templates, or automation tools Solid understanding of clinical drug development processes, data flow and cross-functional dependencies Excellent written and verbal communication skills, with the ability to provide clear, actionable technical feedback to CRO partners and internal stakeholders Highly self-motivated, detail-oriented, and able to manage multiple tasks, adapt to shifting priorities and perform effectively under tight timelines in a fast-paced environment For candidates based in the SFBA area, the salary range for this position is: $180,000 to $210,000. For candidates based outside the SFBA area, the salary range is 150,000 to 190,000. Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Comprehensive benefits package, including competitive employer premium contributions Meaningful stock option grants PTO, sick time, and holiday pay Generous Parental Leave program Pre-tax medical and dependent care programs STD, LTD, Life and AD&D Professional development opportunities Team-building events Fully stocked kitchen Fitness center at our SF headquarters Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year. Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272. #LI-CD

Developing and executing US Medical Affairs strategies, engaging with KOLs, and supporting product launch in a biotech setting. | Requires MD/PhD/PharmD with 10+ years in Medical Affairs, supporting clinical development, and experience with gene therapy or neuroscience. | Encoded Therapeutics is a biotechnology company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases. For more information, please visit www.Encoded.com. Reporting to the VP Clinical/Medical Affairs, the Senior Director of US Medical Affairs is a high-impact leadership role responsible for building and executing the US Medical Affairs strategy as Encoded prepares for BLA and commercial launch. This individual will provide critical input across the product lifecycle and must be a creative thinker capable of producing and executing rapid, high-quality strategic plans. Collaborating closely with cross-functional teams, this is a highly visible internal and externally-facing position to ensure appropriate education, insights, and launch excellence. Responsibilities: US Launch Strategy & Execution Drive the development and execution of the integrated US Medical Affairs strategy, ensuring alignment between clinical development and commercial launch requirements. Design US Field Medical strategy and planning, defining engagement models and territory mapping across US treatment centers, as well as performing field-based engagement and research, as needed. Remain at the forefront of gene therapy science and the competitive landscape to inform internal strategy and external positioning. Provide clinical and competitive insights to shape launch needs and market entry. External Engagement & Execution Cultivate and maintain deep professional relationships with US Key Opinion Leaders (KOLs), healthcare professionals, and industry experts to exchange scientific knowledge, identify clinical trial opportunities, and understand commercial needs. Represent Encoded at major medical congresses, advisory boards, and investigator meetings, presenting complex data with clarity Cross-Functional Collaboration Collaborate closely with Scientific Communications to ensure medical messages, publication plans, and educational materials are scientifically rigorous and strategically aligned with US regulatory standards. Work in lockstep with Patient Advocacy to ensure the patient voice is integrated into clinical trial design and commercial planning. Support development of a comprehensive US HEOR and outcomes research plan to support market access, PBM negotiations, and reimbursement. Partner with Clinical and HEOR teams to design evidence generation activities, including Investigator Sponsored Studies (ISS) and observational research to support regulatory approval and endpoint validation. Partner with Commercial, Regulatory, and Clinical to ensure a seamless transition from development to market. Lead US-specific initiatives, including payer/HTA research and value messaging, launch roadmaps, and center of excellence and patient journey mapping to ensure development of approaches that address the unique opportunities and challenges of gene therapy. Develop and manage long-range budget forecasts and oversee vendors to ensure timely delivery of US medical materials. Educational Background: MD, PhD, PharmD or MD/PhD. Experience: A minimum of 10–12 years in Medical Affairs, including at least 3–5 years specifically supporting Phase 1–3 clinical development and a proven track record in US pre-commercial planning and building US Medical Affairs functions. Strong familiarity with US payer and/or PBM requirements for value demonstration and reimbursement. Prior expertise in gene therapy (ATMPs), neuroscience (e.g., epilepsy/CNS), and/or pediatric rare diseases. Deep understanding of FDA guidelines, OIG compliance, and US-specific requirements for scientific exchange. Strategic thinker while maintaining tactical execution excellence; a self-starter who can produce complex plans and adapt rapidly. Exemplary organizational skills. Exceptional ability to build collaborative partnerships in a matrixed, small-team environment, and to forge strong external relationships with external subject matter experts. Strong skills in interpreting scientific/clinical research and translating it into actionable medical strategy to support treatment access and adoption. Proven success in a startup environment, with the ability to build functions from the ground up and manage multiple complex projects simultaneously. Direct experience identifying, managing, and maintaining relationships with high-performing external consultants and partner agencies. Travel: Ability to travel up to 40%, including international trips for conferences and KOL engagements. For candidates based in the SFBA area, the salary range for this position is: $258,000 to $280,000. For candidates based outside the SFBA area, the salary range is 233,000 to 263,000. Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Comprehensive benefits package, including competitive employer premium contributions Meaningful stock option grants PTO, sick time, and holiday pay Generous Parental Leave program Pre-tax medical and dependent care programs STD, LTD, Life and AD&D Professional development opportunities Team-building events Fully stocked kitchen Fitness center at our San Francisco office Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year. Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272. #LI-CD