Summit Therapeutics

Summit Therapeutics

Associate Director, CMC Statistics

Princeton, NJ · Director

Sponsorship not specified$180k-$200kDetected 3 days ago
PythonData ScienceData VisualizationStatisticsProduct ManagementStakeholder ManagementSupply ChainRecruitingClinical TrialsGMPFDA RegulatorySASLeadershipCommunicationCollaborationProblem SolvingBiostatisticsRegulatory Affairs

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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

  • 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.
  • Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA).

Requirements

  • Minimum of 10 years of industry experience applying statistics to biologics CMC activities in a biopharmaceutical or biotechnology setting.
  • Direct, substantial experience with specification setting, stability trending and shelf-life assessment, analytical method bridging, and comparability assessment is required.
  • Experience applying statistical principles to analytical method qualification, validation, transfer, lifecycle monitoring, and investigations.
  • Working knowledge of applicable ICH guidance, FDA and EMA expectations, cGMP requirements, and data-integrity standards for biologics development and commercialization.
  • Proficiency with one or more statistical software platforms such as JMP, SAS, R, Python, or Minitab, with the ability to produce reproducible, traceable analyses and effective data visualizations.
  • Excellent written and verbal communication skills, with the ability to explain statistical concepts and business implications to non-statistical audiences.
  • All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Nice to have

  • Experience with monoclonal antibodies, bispecific antibodies, or other complex biologics.
  • Experience supporting late-stage development, BLA/MAA submissions, commercial readiness, process validation, PPQ, post-approval changes, and product lifecycle management.
  • Experience operating in an outsourced or virtual development model with CDMOs, CROs, and external testing laboratories.
  • Experience establishing CMC statistical standards, procedures, templates, analysis plans, or governance frameworks.
  • Familiarity with data visualization and reporting tools such as Spotfire, Tableau, or comparable platforms.
  • Key Competencies
  • Scientific and statistical rigor with pragmatic, risk-based judgment.
  • Clear communication and the ability to translate data into actionable CMC decisions.

Compensation

  • $180,000 - $200,000 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.
  • The pay range for this role will vary depending on location.
  • The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.

Company info

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

Equal opportunity

  • Summit is an equal opportunity employer committed to fostering an inclusive workplace.
  • Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.