Senior Manager Biostatistics
Menlo Park, CA, United States
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) or .
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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