Summit Therapeutics

Summit Therapeutics

Director, Statistical Programming

Palo Alto, CA (US) · Director

Sponsorship not specified$203k-$253kDetected 14 days ago
GCPStatisticsExcelClinical TrialsPharmacologyFDA RegulatoryPharmacovigilanceSASExperimental DesignLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingPublic SpeakingOrganizational SkillsMicrosoft OfficeBiostatistics

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

4 transfer filings in the last year, covering 4 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Director of Statistical Programming oversees managing statistical programming projects and creating strategic plans related to clinical trials and medical affairs publications.
  • They are responsible for the structure of the statistical programming function and representing the function in cross-functional activities, particularly in regard to data collection, analysis, and integration of clinical trial data and real-world evidence.

Responsibilities

  • Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
  • Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs.
  • Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
  • Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
  • May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
  • Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
  • Leads efforts to develop programming processes consistent with industry best practices.
  • Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents.
  • Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Nice to have

  • Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
  • Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology.
  • Summit has multiple global Phase 3 clinical studies, including:
  • Non-small Cell Lung Cancer (NSCLC)
  • Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
  • Colorectal Cancer (CRC)
  • Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Skills

  • Experience in supporting oncology phase II/III clinical studies
  • Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
  • In-depth knowledge of CDISC standards
  • Excellent written and verbal communication skills
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines
  • Strong computer and database skills
  • Attention to detail, accuracy and confidentiality
  • Clear and concise oral and written communication skills
  • Excellent organizational skills
  • Critical thinking, problem solving, ability to work independently.
  • Communicate effectively and articulate complex ideas in an easily understandable way
  • Prioritize conflicting demands.

Compensation

  • $203,000 - $253,000 USD
  • 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.
  • The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Benefits

  • Experience, Education and Specialized Knowledge and

Company info

  • Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
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