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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