Associate Director, Statistical Programming

Stoke Therapeutics • Bedford, MA

5h • $214,000 - $236,000 • Hybrid

About The Position

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary approach, the company 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
STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
Stoke’s initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach.
The successful candidate will be responsible for overseeing statistical programming activities within Stoke Therapeutics for one or more programs. The Associate Director/Director, Statistical Programming role will work closely with the Biostatistics and Clinical sub teams, by overseeing vendors and working with internal resources to provide statistical programming support data analysis for clinical trials. This individual may participate in departmental and cross functional technology development and process improvement initiatives. This position will report to the Senior Director, Statistical Programming.

Requirements

• MS in biostatistics or a related field with at least 10 years (or BS with 12 years) of relevant experience
• In-depth knowledge of FDA, EMA and ICH regulations and guidelines
• Experience with BLAs, MAAs and other regulatory submissions
• Hands-on expertise in SAS programming, with strong knowledge of CDISC SDTM, ADaM, Define-XML, and FDA submission standards
• Proven track record of leading clinical studies for statistical programming activities
• Display highly developed organizational leadership qualities, and proven to work on multi-tasks in fast-paced environment with changing priorities
• Good communication skills and ability to work with cross-functional study teams

Nice To Haves

• Experience with SAS LSAF is a plus

Responsibilities

• Work closely with Biostatistics, Data Management and the clinical sub team on the statistical analysis of data to support clinical development, regulatory, and commercialization activities
• Review CRF to ensure that data collected will meet the objectives and the requirements of statistical analyses
• Review statistical analysis plans and shells for tables, figures and listings
• Provide technical and project management leadership for internal statistical programmers or manage CROs to analyze and report complex data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format
• Perform ad hoc and exploratory statistical analyses as needed
• Support regulatory submissions as needed; provide response to regulatory requests independently
• Support the preparation of publications, including manuscripts, posters and oral presentations
• Provide oversight of CROs for outsourced statistical programming activities and lead QC activities for key results generated by CROs
• Provide technical and project management leadership in SAS programs and applications designed to analyze and report complex data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format. Experience with SAS LSAF is a plus
• Perform other duties as assigned

Benefits

• Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level