Principal Biostatistician

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Job description

Principal Biostatistician

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases by up-regulating protein expression with RNA-based medicines. Using the company's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach Stoke is developing antisense oligonucleotides (ASOs) to selectively restore protein levels. The company's first compound, STK-001 is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Dravet syndrome is one of many diseases caused by a haploinsufficiency, in which a loss of ~50% of normal protein levels leads to disease. The company is pursuing treatment for a second haploinsufficient disease, autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Stoke's initial focus is haploinsufficiencies and diseases of the central nervous system and the eye, although proof of concept has been demonstrated in other organs, tissues, and systems, supporting the company's belief in the broad potential for its proprietary approach. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts. For more information, visit or follow the company on Twitter

Position Purpose:

The Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas. He/She participates in the development and review of protocols, analysis plans and file/report specifications, and reviews study setup activities including but not limited to randomization, CRFs and data edits and serves as lead biostatistician on assigned project(s). The Principal Biostatistician performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions as appropriate. He/she also assists in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners.

Key Responsibilities

* Act as the lead or contributing statistician on the clinical development program, individual studies, and associated project teams.
* Produce and deliver statistical analysis strategy for clinical development programs (including target product profiles), clinical development plans, endpoint strategy, statistical analysis plans (SAPs), reports and manuscripts, and statistical analysis required to support development programs.
* Provide statistical input into all phases of clinical development (ensuring regulatory compliance and compliance with good statistical practice) and provide statistical input into the reporting of clinical trial results. Contributes to CSRs, manuscripts, regulatory submissions, and presentations to Congresses.
* Oversee and manage CRO statistical and programming activities to ensure quality deliverables within timelines.
* Author/review DMC charter and serve as an internal independent statistician for assigned clinical trials.
* Analyze clinical trial data and produce accurate results that represent the outcome of the trial, validate statistical outputs, and accurately interpret and clearly communicate statistical results and concepts to non-statisticians.

Required Skills & Experience:

* Ph.D. or Master's degree in Statistics or Biostatistics with 7-10 years' experience in clinical trial setting in the pharmaceutical industry, or equivalent combination of education and experience.
* Working Knowledge of FDA, EMA, and ICH guidance for drug development
* Excellent working knowledge of CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards and associated documentation.
* Serve as statistical lead for a late-phase clinical trial and working knowledge of late-phase clinical trial conduct and execution.
* Excellent presentation skills to interpret statistical concepts and results to clinical development team.
* Proficient in SAS programming and at least one other programming language such as R for statistical analysis.
* Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.
* Fluency in English, both verbal and written communication skills.
* Detail and process oriented.
* Must be able to demonstrate strong project management skills.

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. As we emerge from the COVID-19 pandemic with a high rate of vaccination among our employees, we have begun a return to our physical work environments and resumed some business travel to engage with stakeholders when appropriate. We have established guidelines to 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. For some roles, the necessity of being physically present every day has and continues to be a priority to ensure continued progress with our important work for patients. We will continue to evaluate our practices as we move through this unique period.

Company policy requires that all employees and all new hires be fully vaccinated against COVID-19 by the earlier of November 15 or when the new Department of Labor rules regarding testing and vaccinations take effect. By applying, you are confirming that, if hired, you can satisfy this express condition of employment. At present, an individual is deemed "fully vaccinated" when that person has received, at least 14 days prior, either the second dose in a two-dose COVID-19 vaccine series (e.g., Pfizer or Moderna) or a single-dose COVID-19 vaccine (e.g., Johnson & Johnson). The Company will make reasonable accommodations under applicable law for qualified individuals to enable them to perform the essential functions of the job, unless doing so would create an undue hardship for the Company.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position will be located in Cambridge, MA

Travel:

This position will require approximately 5% travel.

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 should apply directly to the position listed on Stoke's website:

Stoke participates in E-Verify