Stoke Therapeutics
Director/Senior Director, Statistical Programmer
Stoke Therapeutics, Bedford, Massachusetts, us, 01730
About Stoke:
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Stoke's initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals. Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach. Position Purpose: We are seeking a highly experienced and strategic Director/Senior Director of Statistical Programmer to lead and grow our statistical programming function. This role will be instrumental in supporting our expanding clinical development pipeline, including a pivotal phase 3 trial. The ideal candidate will bring deep technical expertise, leadership experience, and collaborative mindset to help drive successful regulatory submissions and clinical trial execution. The Director/Senior Director will have proven leadership ability in a fast paced, environment and interact with all levels of internal staff as well as external stakeholders, including managing external consultants and CROs. This position will report into the Executive Director, Head of Biostatistics. Key Responsibilities: Provide strategic oversight for statistical programming activities across multiple development programs. Serve as the statistical programmer functional lead for the phase 3 pivotal trial, ensure robust data and analysis workflows to support NDA/MAA submission, including integrated summaries (ISE/ISS), working closely with regulatory, biostatistics, and clinical data management teams Oversee and perform quality control (QC) review of datasets, tables, listing and figures (TLFs) generated by CROs and vendors to ensure accuracy, consistency, and regulatory compliance. Ensure adherence to CDISC standards (SDTM, ADaM, Define-XML) and regulatory agency requirements. Guide programming support for exploratory and ad-hoc analyses to generate clinical and scientific insights. Establish and implement processes to ensure quality control, traceability, and reproducibility of analyses. Develop and maintain programming standards, SOPs, and QC procedures that align with regulatory expectations. Manage vendor relationships to ensure deliverables are on time, high-quality, and audit-ready. Partner cross-functionally to support clinical study reports (CSRs), data monitoring committees, and regulatory interactions. Provide leadership in planning for future in-house statistical programming capabilities, including team building and process development as needed. Why Join Us: Opportunity to build the statistical programming function in a growing biotech. Direct involvement in advancing multiple drug candidates, including a pivotal phase 3 program. Small, agile team environment with visibility and impact at the highest levels of the company. Mission-driven organization focused on developing disease-modifying therapies for patients with high unmet medical need. Required Skills & Experience: Master's degree (or higher) in statistics, Computer Science, Mathematics, or related field. 10+ years statistical programming experience in biotech industry. Proven track record leading programming for pivotal phase 3 trials and regulatory submissions (NDA/MAA/BLA). Hands-on expertise in SAS and R programming, with strong knowledge of CDISC SDTM, ADaM, Define-XML, and FDA submission standards. Experience managing external vendor/CROs in a global clinical development environment. Experience with machine learning programming is a plus. Knowledge of AI/ML is a plus. Location(s): This position is a hybrid position with an office setting based in our Bedford, MA location. Travel: This position will require approximately 5% travel. Culture & Values: At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do. Benefits & Compensation: At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible. Interested candidates:
Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center. For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx. All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status. Stoke participates in E-Verify.
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Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Stoke's initial focus for its TANGO platform is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals. Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach. Position Purpose: We are seeking a highly experienced and strategic Director/Senior Director of Statistical Programmer to lead and grow our statistical programming function. This role will be instrumental in supporting our expanding clinical development pipeline, including a pivotal phase 3 trial. The ideal candidate will bring deep technical expertise, leadership experience, and collaborative mindset to help drive successful regulatory submissions and clinical trial execution. The Director/Senior Director will have proven leadership ability in a fast paced, environment and interact with all levels of internal staff as well as external stakeholders, including managing external consultants and CROs. This position will report into the Executive Director, Head of Biostatistics. Key Responsibilities: Provide strategic oversight for statistical programming activities across multiple development programs. Serve as the statistical programmer functional lead for the phase 3 pivotal trial, ensure robust data and analysis workflows to support NDA/MAA submission, including integrated summaries (ISE/ISS), working closely with regulatory, biostatistics, and clinical data management teams Oversee and perform quality control (QC) review of datasets, tables, listing and figures (TLFs) generated by CROs and vendors to ensure accuracy, consistency, and regulatory compliance. Ensure adherence to CDISC standards (SDTM, ADaM, Define-XML) and regulatory agency requirements. Guide programming support for exploratory and ad-hoc analyses to generate clinical and scientific insights. Establish and implement processes to ensure quality control, traceability, and reproducibility of analyses. Develop and maintain programming standards, SOPs, and QC procedures that align with regulatory expectations. Manage vendor relationships to ensure deliverables are on time, high-quality, and audit-ready. Partner cross-functionally to support clinical study reports (CSRs), data monitoring committees, and regulatory interactions. Provide leadership in planning for future in-house statistical programming capabilities, including team building and process development as needed. Why Join Us: Opportunity to build the statistical programming function in a growing biotech. Direct involvement in advancing multiple drug candidates, including a pivotal phase 3 program. Small, agile team environment with visibility and impact at the highest levels of the company. Mission-driven organization focused on developing disease-modifying therapies for patients with high unmet medical need. Required Skills & Experience: Master's degree (or higher) in statistics, Computer Science, Mathematics, or related field. 10+ years statistical programming experience in biotech industry. Proven track record leading programming for pivotal phase 3 trials and regulatory submissions (NDA/MAA/BLA). Hands-on expertise in SAS and R programming, with strong knowledge of CDISC SDTM, ADaM, Define-XML, and FDA submission standards. Experience managing external vendor/CROs in a global clinical development environment. Experience with machine learning programming is a plus. Knowledge of AI/ML is a plus. Location(s): This position is a hybrid position with an office setting based in our Bedford, MA location. Travel: This position will require approximately 5% travel. Culture & Values: At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do. Benefits & Compensation: At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible. Interested candidates:
Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center. For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx. All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status. Stoke participates in E-Verify.
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