Senior Manager Biostatistics

Highly Competitive
  1. Permanent
  2. Statistics
  3. United States
Menlo Park, USA
Posting date: 06 Jun 2024
60780

Senior Manager for Biostatistics - Permanent - Menlo Park, California CA

Proclinical is seeking a dedicated and analytical Senior Manager for Statistics to be based in Menlo Park, California for a permanent position.

Primary Responsibilities:

This role will focus on overseeing the statistical aspects of clinical studies, collaborating with various teams and ensuring regulatory compliance. The ideal candidate will have a strong interest in statistical research and the application of novel methods.

Skills & Requirements:

  • Knowledge of global regulatory guidance and submission requirements.
  • Proficiency in statistical analysis methodologies for rare disease studies.
  • Strong interest in statistical research and novel methods application.
  • Knowledge of missing data handling, multiple comparisons, survival analysis, and simulation techniques.
  • Proficiency in SAS and R programming, and sample size calculations.
  • Familiarity with CDISC SDTM and ADaM specifications.
  • Excellent analytical, communication, and organizational skills.
  • Ability to apply complex statistical methods and interpret results.
  • Excellent interpersonal, problem-solving, and negotiation skills.
  • Ability to handle uncertainty with creative problem-solving.

The Senior Manager for Biostatistics' responsibilities will be:

  • Collaborate with various teams on trial design and execution.
  • Write statistical analysis plans and participate in regulatory document preparation.
  • Plan and ensure timely regulatory filings.
  • Work with Statistical Programming on analyses and validation.
  • Oversee execution of statistical components by internal teams and CROs.
  • Stay updated with regulatory requirements and scientific developments.
  • Assist internal audits for regulatory compliance.
  • Participate in the development of statistical SOPs.
  • Identify and solve technical issues in study design, conduct, and analysis.
  • Ensure consistency and adherence to standards across compounds and therapeutic areas.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323 306 2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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