What are the responsibilities and job description for the Director/Senior Director, Biostatistics position at Stoke Therapeutics?
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Director/Senior Director, Biostatistics develops statistical plans for the Company’s products and product candidates in all phases of clinical development (Phases 1-4). The Director/Senior Director will be a key member of a highly collaborative Clinical Development Operations team and lead and manage external consultants and CRO’s. The Director/Senior Director will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff as well as external stakeholders, including, but not limited to the FDA and other health authorities, CRO’s, Key Opinion Leaders and Advisory Boards and Committees. This position will report into the Head of Biostatistics.
Key Responsibilities:
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Cambridge, 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:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter 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.
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Director/Senior Director, Biostatistics develops statistical plans for the Company’s products and product candidates in all phases of clinical development (Phases 1-4). The Director/Senior Director will be a key member of a highly collaborative Clinical Development Operations team and lead and manage external consultants and CRO’s. The Director/Senior Director will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff as well as external stakeholders, including, but not limited to the FDA and other health authorities, CRO’s, Key Opinion Leaders and Advisory Boards and Committees. This position will report into the Head of Biostatistics.
Key Responsibilities:
- 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
- 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.
- Develop and propose Statistical Analysis Plans for the Company’s portfolio of product candidates from Phase 1 through Phase 3, New Drug Application(s) and post approval studies in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors and advisors.
- Provide statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations.
- Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities.
- Represent the Company at scientific and medical meetings, including, for example, Investigator Meetings, Advisory Boards, and other interactions with Key Opinion Leaders.
- Oversee the biostatistics function in CRO’s; manage scope of work and relationships with other external statistician consultants as needed.
- Oversee the programming function in CRO’s to ensure outputs are as planned
- Collaborate closely with Clinical Development, Data Management, Clinical Operations and Medical Writing and other internal departments as required.
- Maintain current knowledge of relevant issues related to statistics and trial design, drug development, Health Authority regulations, and competitive trends to inform input and recommendations.
- Develop and maintain relevant Standard Operating Procedures and other policies, procedures, and systems relevant to the department.
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- D. or Master’s degree in Statistics or Biostatistics with 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
- 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
- Deep and broad experience in all aspects of Phase 1 to 3 clinical trial design, execution and data interpretation in both efficacy and safety; ideally has had a lead role in developing Statistical Analysis Plans for NDA preparation and defense
- Experience in CRO selection, contracting and management.
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
- Excellent presentation skills to interpret statistical concepts and results to non-statisticians.
- 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
- Excellent verbal and written communication
- Detail and process
- Must be able to demonstrate strong project management skills.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Cambridge, 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:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter 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.
