Exel

Exel

Senior Biostatistics Director

Alameda, CA · Director

Sponsorship not specified$217k-$308kDetected 10 days ago
StatisticsProject ManagementNegotiationClinical TrialsFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs

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odds of building a lasting career here

61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
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

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 9 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

  • Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
  • Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies.
  • Supervisory Responsibilities: • No supervisory responsibilities.

Responsibilities

  • Work with department head to develop and implement department standards and practices.
  • Direct the statistical design, conduct, and analysis of clinical trials in all phases.
  • Review protocols and case report forms for soundness of trial design.
  • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
  • Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
  • Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
  • Develops and/or applies statistical theories, methods and software.
  • Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
  • Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions.
  • Manages timelines, deliverables and budgets of contract research organizations.

Requirements

  • BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of fifteen years of related experience
  • MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience
  • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Nice to have

  • Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
  • Preferably led a phase III clinical trial.
  • In-depth knowledge of CDISC standards.
  • Direct experience with FDA/EU Authority preferred.

Skills

  • Developed/reviewed SDTM/ADaM specifications.
  • Excellent knowledge of FDA/EU statistical guidelines.
  • Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety.
  • Project management and contract negotiation with outside vendors.
  • Develops technical and/or business solutions to complex problems.
  • Applies strong analytical and business communication skills.
  • Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
  • Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
  • Education/Experience:
  • BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of fifteen years of related experience; or,
  • MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,

Compensation

  • The base pay range for this position is $216,500 - $307,500 annually.
  • The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.

Benefits

  • The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
  • Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.

Company info

  • Regularly interacts with executives and/or major customers.
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