Associate Director, Biostatistics
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT US
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
SUMMARY
The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross functional technology development and process improvement initiatives. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office or possible to be remote.
RESPONSIBILITIES
- Serve as a lead statistician and manage statistical efforts for multiple clinical studies
- Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
- Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
- Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
- Work with statistical programmers or CROs to generate tables, figures and listings
- Support ongoing safety review and DMC review of the clinical development program/study teams
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
- Support regulatory submissions as needed
- Support the preparation of publications, including manuscripts, posters and oral presentations
- Accountable for the performance and results at a study level. Ensures the implementation of biostatistics decisions and best practices
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
QUALIFICATIONS
- PhD in statistics or a related field with at least 6 years (or MS with at least 9 years) of relevant clinical trial experience
- Knowledge of statistical methods for clinical trials
- In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
- Experience with BLAs, MAAs and other regulatory submissions is a plus
- Proficient in statistical programming (SAS is required and R is a plus)
- Experience with trial design software (e.g., EAST)
- Good communication skills and ability to work with cross-functional study teams
- Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Good analytical and problem solving skills
- Positive, outgoing and collaborative attitude
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
SUMMARY
The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross functional technology development and process improvement initiatives. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office or possible to be remote.
RESPONSIBILITIES
- Serve as a lead statistician and manage statistical efforts for multiple clinical studies
- Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
- Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
- Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
- Work with statistical programmers or CROs to generate tables, figures and listings
- Support ongoing safety review and DMC review of the clinical development program/study teams
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
- Support regulatory submissions as needed
- Support the preparation of publications, including manuscripts, posters and oral presentations
- Accountable for the performance and results at a study level. Ensures the implementation of biostatistics decisions and best practices
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
QUALIFICATIONS
- PhD in statistics or a related field with at least 6 years (or MS with at least 9 years) of relevant clinical trial experience
- Knowledge of statistical methods for clinical trials
- In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
- Experience with BLAs, MAAs and other regulatory submissions is a plus
- Proficient in statistical programming (SAS is required and R is a plus)
- Experience with trial design software (e.g., EAST)
- Good communication skills and ability to work with cross-functional study teams
- Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Good analytical and problem solving skills
- Positive, outgoing and collaborative attitude
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
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