• Associate Director Statistical Programming

    Actalent (Waltham, MA)


    Job Title: Associate Director Statistical ProgrammingJob Description

     

    As an Associate Director of Statistical Programming, you will independently lead and represent the Quantitative Sciences team for all statistical activities, including statistical programming for assigned studies across programs. You will ensure compliance with regulatory guidelines and maintain open communication with both internal and external teams.

    Responsibilities

    + Lead and oversee all statistical activities, including statistical programming for assigned studies.

    + Ensure compliance with regulatory and ICH guidelines, GCPs, company guidelines, and SOPs.

    + Establish and maintain positive communication with internal teams and third-party vendors.

    + Oversee contracted vendors to ensure data accuracy and timely delivery of analyses.

    + Monitor the quality of all statistical programming deliverables.

    + Assist in user acceptance testing of clinical databases.

    + Collaborate cross-functionally to design and develop study documents, including SDTM and ADaM packages.

    + Participate in ongoing cross-functional data reviews to identify errors and discrepancies.

    + Review and approve analysis data transfers and other statistical deliverables.

    + Generate and disseminate project status reports to management.

    + Participate in quantitative science initiatives, including evaluating technology vendors, authoring SOPs, and establishing data analysis standards.

    Essential Skills

    + Master's degree or higher in statistics, mathematics, computer science, or a related discipline.

    + Minimum of 10 years of experience in a pharmaceutical or CRO environment with Phase I, II, and III studies.

    + Expertise in SAS.

    + Experience in developing SDTM and ADaM packages and analysis output.

    + Extensive experience in managing external vendors and internal FSPs.

    + Thorough knowledge of regulatory rules and guidelines.

    + Excellent organizational skills and attention to detail.

    + Effective written and verbal communication skills.

    + Ability to prioritize and manage multiple projects.

    + Critical thinking and proactive problem-solving abilities.

    + Ability to work independently with initiative and sound judgment.

    + Strong commitment to ethical standards.

    + Proficiency with Microsoft Office suite.

    Additional Skills & Qualifications

    + Ability to travel up to 5%.

    Work Environment

    The work environment involves leading statistical programming activities in a cross-functional setting, collaborating with internal and external teams, and ensuring compliance with industry standards. The role may require travel up to 5% of the time.

    Pay and Benefits

    The pay range for this position is $165000.00 - $180000.00/yr.

    Viridian offers a comprehensive benefits package including:

    Competitive pay and stock options for all employeesMedical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependentsFertility and mental health programsShort- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious mental, financial, and proactive physical health programs covered by Viridian

     

    Workplace Type

     

    This is a fully remote position.

     

    Application Deadline

     

    This position is anticipated to close on Jun 12, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.