Sr. Manager, Statistical Programming

3 weeks ago

Menlo Park, United States Summit Therapeutics Sub, Inc. Full time
Job DescriptionJob Description

Overview of Role:

The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.

Role and Responsibilities:

  • Lead and manage statistical programmers, providing mentorship, technical guidance, and career development opportunities.
  • Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.
  • Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on oncology-specific data structures and endpoints.
  • Collaborate with Biostatistics to implement complex statistical analyses for oncology trials, including time-to-event analyses, response evaluations, and biomarker assessments.
  • Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (including NDA/BLA), and publications.
  • Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.
  • Lead the development and maintenance of standardized oncology-specific analysis datasets, programs, and macros to improve efficiency and consistency across projects.
  • Manage resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.
  • Serve as the statistical programming representative in cross-functional study teams and external collaborations.
  • Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.
  • Stay current with evolving trends in oncology clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.
  • Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.

Experience, Education and Specialized Knowledge and Skills:

  • Master's degree in Statistics, Biostatistics, Computer Science, or a related field.
  • Minimum 10 years of experience in statistical programming within the pharmaceutical/biotech industry, with at least 5 years focused on oncology trials and 3+ years in a leadership role.
  • Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.
  • Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures.
  • In-depth knowledge of oncology-specific endpoints, such as progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and RECIST criteria.
  • Experience with statistical analysis methods commonly used in oncology trials, including time-to-event analyses, and methods for handling missing data.
  • Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.
  • Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, ADaM spec, Define files, Reviewer's Guide).
  • Demonstrated experience in leading and managing statistical programming teams, including experience with global and/or outsourced teams.
  • Strong project management skills, with the ability to prioritize and manage multiple studies simultaneously.
  • Excellent problem-solving skills and the ability to provide innovative solutions to complex programming challenges in clinical research.
  • Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.
  • Experience with R and Python programming languages is highly desirable.
  • Familiarity with data standards organizations (e.g., CDISC, PhUSE) and industry initiatives.

Preferred Qualifications:

  • Experience with oncology immunotherapy trials and associated efficacy endpoints (e.g., iRECIST).
  • Knowledge of electronic data capture (EDC) systems and clinical data management processes.
  • Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau).
  • Familiarity with cloud-based computing environments and big data technologies.
  • Active participation in industry conferences and working groups.

The pay range for this role is $165,000 to $190,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.

  • Senior Manager, Statistical Programming Lead

    13 hours ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Statistical Programming to lead our statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies.Key ResponsibilitiesLead and manage a team of statistical programmers, providing mentorship, technical...

  • Manager, Statistics

    1 month ago

    Florham Park, New Jersey, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

  • Manager, Statistics

    3 months ago

    Florham Park, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in...

  • Sr. Payroll Compliance Analyst

    1 month ago

    Menlo Park, United States Addison Group Full time

    Job DescriptionJob DescriptionRole: Sr Payroll Compliance AnalystLocation: Menlo Park (Onsite)Duration: 24 monthsPay Rate: $ $55-$70 / hourInternal Job ID: 10018028Are you looking for a growth opportunity for a reputable company with a positive work environment? Our client is looking for a (Job Title) to join their team. Please contact us today to discuss...

  • Manager, Statistics

    2 months ago

    Florham Park, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in...

  • Sr Program Manager, Technical Learning

    1 month ago

    Overland Park, Kansas, United States TMobile Full time

    Be unstoppable with usT-Mobile is synonymous with innovation–and you could be part of the team that disrupted an entire industry We reinvented customer service, brought real 5G to the nation, and now we're shaping the future of technology in wireless and beyond. Our work is as exciting as it is rewarding, so consider the career opportunity below as your...

  • Experienced Technical Program Manager

    4 hours ago

    Menlo Park, California, United States US Tech Solutions Full time

    Job SummaryWe are seeking an experienced Technical Program Manager to join our team at US Tech Solutions. As a Technical Program Manager, you will be responsible for developing and executing internal program strategy, balancing the needs of multiple stakeholders, and driving execution through influence or direct intervention.Key ResponsibilitiesProgram...

  • Sr Manufacturing Engineer

    3 weeks ago

    Menlo Park, United States ATR International Full time

    We are seeking a Sr Manufacturing Engineer for a very important client Participate and contribute towards new product development of pharmaceutical drug product in support of company's strategic plan.In this role, the candidate will be responsible for the overall operations and manufacturing engineering activities related to planning and execution of builds...

  • RWSHR - Group Sales Manager

    3 months ago

    Menlo Park, United States Group Sales Manager Full time

    KEY RESPONSIBILITIESJob SummaryTarget, solicit and cultivate business within the group market segment, with efforts directed towards room night revenue generation, as well as securing group affiliated meeting and food & beverage revenues.Essential Duties and Responsibilities – (Key Activities)Solicit new and develop existing accounts to meet/exceed revenue...

  • Sr Manufacturing Engineer

    2 weeks ago

    Menlo Park, United States ATR International Full time

    We are seeking a Sr Manufacturing Engineer for a very important client Participate and contribute towards new product development of pharmaceutical drug product in support of company's strategic plan.In this role, the candidate will be responsible for the overall operations and manufacturing engineering activities related to planning and execution of builds...

  • Sr. Events Program Manager

    3 weeks ago

    Overland Park, United States Augeo Affinity Marketing Full time

    Job DescriptionJob DescriptionDescription:Hello, we’re Augeo Experience. We curate signature experiences – events, incentives, gifting programs, strategic meetings, marketing campaigns, and more. With a strategy first approach, we amplify our clients’ brands and strengthen their communities to create collaborative experiences and long-term strategies...

  • Sr. Events Program Manager

    2 days ago

    Overland Park, United States Augeo Affinity Marketing Full time

    Job DescriptionJob DescriptionDescription:Hello, we're Augeo – we are a global leader in enterprise-level engagement and loyalty platform technology, delivering compelling experiences and fostering meaningful connections for employees, consumers, members and channel partners across many industries and verticals. We serve hundreds of clients, including...

  • Senior Manager, Clinical Data Management

    2 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Senior Manager, Clinical Data Management

    6 days ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Program Manager

    1 month ago

    Menlo Park, United States Ursus, Inc. Full time

    JOB TITLE: Program Manager LOCATION: Menlo Park, CA (onsite) DURATION: 7 month contract PAY RANGE: $68 - $78/hrTOP 3 SKILLS:Demonstrated ability to influence change and drive project management initiatives within large organizations.Extensive experience in managing end-to-end projects or programs, particularly in non-IT fields related to financial systems...

  • Program Manager

    2 months ago

    Menlo Park, United States Ursus, Inc. Full time

    JOB TITLE: Program Manager LOCATION: Menlo Park, CA (onsite) DURATION: 7 month contract PAY RANGE: $68 - $78/hrTOP 3 SKILLS:Demonstrated ability to influence change and drive project management initiatives within large organizations.Extensive experience in managing end-to-end projects or programs, particularly in non-IT fields related to financial systems...

  • Sr. Clinical Trial Associate

    4 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:The CTA/Sr. CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA/Sr. CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting...

  • rwshr -

    4 weeks ago

    Menlo Park, California, United States Group Sales Manager Full time

    KEY RESPONSIBILITIESJob SummaryTarget, solicit and cultivate business within the group market segment, with efforts directed towards room night revenue generation, as well as securing group affiliated meeting and food & beverage revenues.Essential Duties and Responsibilities – (Key Activities)Solicit new and develop existing accounts to meet/exceed revenue...

  • Engineering Program Manager

    3 months ago

    Menlo Park, United States META Full time

    Meta is seeking an Engineering Program Manager, Technical Operations to join our Data Center Engineering and Construction (DEC) team. Our data centers are the foundation upon which our rapidly growing infrastructure operates, and our innovative services are delivered as we continue our mission to build community and bring the world closer together. The...

  • Principal Clinical Data Manager

    7 days ago

    Menlo Park, United States Clinvia LLC Full time

    Responsibilities Main point of client contact and study team for all DM related matters Execute all DM start-up activities, including the development and maintenance of eCRFs Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review Ensure clinical data within EDC is in quality to...