Associate Director, Statistical Programming

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.

SUMMARY

The successful candidate will be responsible for overseeing statistical programming activities within Genetix bio.  The Associate Director, Statistical Programming role will be working closely with Biostatistics and clinical subteam, overseeing the vendor and working with internal resource to provide statistical programming support to data analysis for clinical trials.  This individual may 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. Potentially could consider remote.

RESPONSIBILITIES

• Work closely with Biostatistics, Data Management and the clinical subteam on 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
• Provides 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
• Responsible for coaching, mentoring, and performance management of direct reports and junior programmers
• Perform other duties as assigned

QUALIFICATIONS

• MS in biostatistics/epidemiology 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
• Display highly developed organizational leadership qualities, and proven to work on multi-tasks in an extremely fast-paced environment with changing priorities
• Good communication skills and ability to work with cross-functional study teams
• Good analytical and problem-solving skills
• Positive, outgoing and collaborative attitude
• Ability to mentor junior statistical programmers

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.