Manager Of Programming, Statistics

Job title: Manager Of Programming, Statistics

Company: Actalent


Job description: Job Title: Manager of Programming, StatisticsJob DescriptionWe are seeking a Manager of Programming, Statistics to join our team dedicated to developing innovative medicines for autoimmune and rare diseases. You will play a critical role in statistical programming activities across various studies and programs, ensuring high-quality clinical data and analysis are delivered timely and within budget.Responsibilities

• Independently lead and represent all statistical activities, including statistical programming for assigned studies across programs.
• Ensure compliance with regulatory guidelines, ICH guidelines, GCPs, and company SOPs.
• Establish rapport and maintain open communication with internal teams and external third-party teams.
• Oversee contracted vendors or vendor groups within CROs to ensure data and analyses are complete, accurate, and delivered on time.
• Monitor and track the quality of all statistical programming deliverables, ensuring audit practices validate quality and assurance.
• Assist in user acceptance testing of clinical databases.
• Work cross-functionally and with CROs to design and develop study documents, including SDTM and ADaM packages and analysis output.
• Participate in ongoing cross-functional data reviews to identify errors and discrepancies timely.
• Review and approve analysis data transfers and other statistical deliverables.
• Generate and disseminate project status reports to management.
• Participate in quantitative science initiatives, such as evaluating technology vendors, authoring and reviewing SOPs, and establishing data analysis standards.

Essential Skills

• Master’s degree or higher in statistics, mathematics, computer science, or related discipline.
• Minimum of 5 years of experience in pharmaceutical or CRO environments, including Phase I, II, and III studies.
• Proficiency in SAS programming.
• Proficiency in development of SDTM, ADaM packages, and analysis output.
• Experience in managing external vendors.
• Thorough knowledge of regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Ability to set priorities and manage multiple projects.
• Critical thinking and proactive problem-solving skills.
• Independent work capability with initiative, flexibility, and sound judgment.
• Commitment to ethical standards.
• Proficiency with Microsoft Office suite.
• Ability to travel up to 5%.

Additional Skills & Qualifications

• Experience in Phase I, II, and III studies from start-up through closure.
• Knowledge of CDISC standards.

Work EnvironmentThis role may be based in Waltham, MA, as a hybrid role with three days in the office or fully remote, requiring travel to headquarters for meetings. We offer a collaborative culture that values data-driven decisions, thoughtful risk-taking, and open communication. Our team consists of talented professionals committed to improving patients’ lives, balancing personal and professional ambitions, and contributing at high levels.Pay and BenefitsThe pay range for this position is $140000.00 – $165000.00/yr.Viridian offers a comprehensive benefits package including:Competitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
Fertility and mental health programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various mental, financial, and proactive physical health programs covered by ViridianWorkplace TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on Jun 2, 2025.About ActalentActalent 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 for other accommodation options.

Expected salary: $140000 – 165000 per year

Location: Waltham, MA

Job date: Wed, 21 May 2025 00:04:24 GMT

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