Stoke Therapeutics
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.
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.
Position Purpose:
We are seeking a highly experienced and strategic 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. 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. 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. This position is a hybrid position with an office setting based in our Bedford, MA location. The position will require approximately 5% travel. 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. 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. Stoke Therapeutics offers 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). 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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We are seeking a highly experienced and strategic 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. 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. 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. This position is a hybrid position with an office setting based in our Bedford, MA location. The position will require approximately 5% travel. 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. 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. Stoke Therapeutics offers 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). 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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