Talent.com
Director, Statistical Programming Somerville, Massachusetts, United States

Director, Statistical Programming Somerville, Massachusetts, United States

Genetix Biotherapeutics, Inc.Somerville, MA, United States
4 days ago
Job type
  • Full-time
Job description

Somerville, Massachusetts, United States,

About Genetix Biotherapeutics

At Genetix every role has meaning, every team member is respected. When you join Genetix Biotherapeutics, 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 and better days. We are doers, thinkers and collaborators who embrace and live by our values :

  • Persist for Purpose
  • Stay humble and curious
  • Keep it real
  • Celebrate (sm)all wins

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 leading Statistical Programming function within bluebird bio. The Director, Statistical Programming role will report to the Senior Director, Biostatistics and will be working closely with the Biostatistics and clinical sub team, overseeing vendors and working with internal resources to provide statistical programming support for data analysis of clinical trials and registry studies. This role also includes overseeing the programming function and providing both technical and managerial leadership. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

  • Lead and manage all activities within the Statistical Programming function, ensuring integration with other departments.
  • Provide technical leadership, timely delivery and strategic direction for regulatory submissions, including responses to health authority requests.
  • Evaluate project plans and timelines, effectively allocate resources, and ensure timely delivery of key milestones.
  • Manage, mentor and develop team members, fostering continuous improvement in processes and service delivery.
  • Manage vendor relationships, ensuring quality and alignment with internal standards.
  • Review and enhance standard operating procedures (SOPs) within Statistical Programming; contribute to SOPs and work instructions across related functions.
  • Collaborate with Biostatistics, Data Management, and clinical teams on statistical analyses supporting development, regulatory, and commercialization efforts.
  • Provide technical and project management leadership for internal programmers and CROs in the generation of Tables, Listings, and Figures, and in the preparation of SDTM and ADaM datasets in CDISC format.
  • Conduct on ad hoc and exploratory statistical analyses as needed.
  • Perform additional duties as assigned.
  • QUALIFICATIONS

  • Master’s degree in Biostatistics or a related field with a minimum of 10 years (or Bachelor’s degree with 12+ years) of relevant experience
  • Deep understanding of FDA, EMA and ICH regulations and guidelines
  • Proven experience with regulatory submissions including BLAs and MAAs
  • Strong organizational leadership skills with the ability to manage multiple priorities in a fast-paced environment
  • Good communication skills and ability to work effectively with cross-functional teams
  • Strong analytical and problem-solving capabilities.
  • Collaborative, proactive, and positive attitude.
  • Demonstrated ability to mentor and inspire confidence across teams.
  • 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.

    Your privacy is important to us. Genetix, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located here.

    Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information.

    #J-18808-Ljbffr

    Create a job alert for this search

    Director Programming • Somerville, MA, United States

    Related jobs
    • Promoted
    Director, Real-World Biostatistics

    Director, Real-World Biostatistics

    GlaxoSmithKlineWaltham, MA, United States
    Full-time
    Director, Real-World Biostatistics.This position requires providing deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commerc...Show moreLast updated: 4 days ago
    • Promoted
    Director, Real-World Biostatistics

    Director, Real-World Biostatistics

    Gamma Phi Omega InternationalWaltham, MA, United States
    Full-time
    Director, Real-World Biostatistics.This position requires providing deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commerc...Show moreLast updated: 4 days ago
    • Promoted
    Scientific Director Oncology – ETCT Innovation

    Scientific Director Oncology – ETCT Innovation

    GlaxoSmithKlineWaltham, MA, United States
    Full-time
    Site Name : USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date : Oct 17 2025.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.Our...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Clinical and Translational Imaging

    Associate Director, Clinical and Translational Imaging

    Novartis Group CompaniesCambridge, MA, United States
    Full-time
    The Biomarker Development (BMD) group at the Novartis Institutes for BioMedical Research (NIBR) is seeking a Senior Expert Imaging to join our Clinical Imaging team and actively provide strategic, ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Biostatistics

    Senior Director, Biostatistics

    Cedent ConsultingBoston, MA, United States
    Full-time
    As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Data and Analytics

    Senior Director, Data and Analytics

    argenx SEBoston, MA, United States
    Full-time
    For the expansion of the Data and Analytics capability within Business Information Systems (BIS) team argenx is looking for a highly analytical and strategic leader to drive data-informed decision ...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    Cross Country ConsultingBoston, MA, United States
    Full-time
    From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Computational Chemistry

    Associate Director, Computational Chemistry

    TakedaBoston, MA, United States
    Full-time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...Show moreLast updated: 1 day ago
    • Promoted
    Director, Statistical Programming

    Director, Statistical Programming

    Dyne TherapeuticsWaltham, MA, United States
    Full-time
    Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central ...Show moreLast updated: 4 days ago
    • Promoted
    Associate Director, Statistics (Hybrid)

    Associate Director, Statistics (Hybrid)

    Takeda PharmaceuticalsBoston, MA, United States
    Full-time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...Show moreLast updated: 4 days ago
    • Promoted
    Director, Biostatistics

    Director, Biostatistics

    Aura BiosciencesBoston, MA, United States
    Full-time
    Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is cu...Show moreLast updated: 4 days ago
    • Promoted
    Director, Real-World Biostatistics

    Director, Real-World Biostatistics

    GSKWaltham, MA, United States
    Full-time
    Director, Real-World Biostatistics.RWB) is a key role focused on advancing strategy and methodology in the entire course of drug / vaccine development using real-world data (RWD) within the enterpris...Show moreLast updated: 4 days ago
    • Promoted
    • New!
    Director, Actuarial Analytics – Healthcare Utilization & Revenue Forecasting

    Director, Actuarial Analytics – Healthcare Utilization & Revenue Forecasting

    athenahealthBoston, Massachusetts, United States
    Full-time
    Join us as we work to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all. Business Title Director, Actuarial Analytics – Healthcare Utilization & ...Show moreLast updated: 4 hours ago
    • Promoted
    Director, Statistical Programming

    Director, Statistical Programming

    Dyne TxWaltham, MA, United States
    Full-time
    Our commitment to people with neuromuscular diseases.Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.We are develo...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Biostatistics

    Director, Biostatistics

    Rapport TherapeuticsBoston, MA, United States
    Full-time
    Rapport Therapeutics is focused on precision neuromedicine.Our led programs include RAP-219, with indications targeting focal epilepsy and trials in neuropathic pain and bipolar disorder.Biostatist...Show moreLast updated: 1 day ago
    • Promoted
    Senior Director of Biostatistics

    Senior Director of Biostatistics

    Formation BioBoston, MA, United States
    Full-time
    Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.Advancements in AI and drug discovery are creating more candidate drugs than the ind...Show moreLast updated: 4 days ago
    • Promoted
    Director, RWE & Biostatistics

    Director, RWE & Biostatistics

    PutnamBoston, MA, United States
    Full-time
    Putnam is seeking to hire Director of Real-World Evidence [RWE] & Biostatistics.This role offers the opportunity to join a global team of more than 30 statisticians, mathematicians, epidemiologists...Show moreLast updated: 1 day ago
    • Promoted
    • New!
    Director Research & Special Funds Accounting Tufts Medical Center

    Director Research & Special Funds Accounting Tufts Medical Center

    Tufts Medical CenterBoston, MA, United States
    Temporary
    Tufts Medical Center is a world-renowned academic medical center that has been providing exceptional care across New England for over two centuries. Our clinicians are dedicated to delivering innova...Show moreLast updated: 9 hours ago