Senior Manager Biostatistics

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.