Senior Biostatistician:
Cepheid

886954109
Cepheid
Sunnyvale California
Pharmaceutical
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Description
Overview:
The position will support assay development and clinical studies for oncology IVD products by providing statistical input in the planning, analysis and reporting of pre-clinical, clinical, and post-launch studies conducted by the Medical and Scientific Affairs and Clinical Affairs teams. This position will be a point of contact for regulatory questions pertaining to the biostatistics function. The position will also provide biostatistical support for analytical studies such as precision and reproducibility, interfering substances, limit of detection (LOD), exclusivity and inclusivity, method comparisons, accuracy, and linearity carried out by the oncology R&D team.

Responsibilities:
  • Provide statistical input for study protocols and data collection instruments, develop statistical analysis plans, and compute sample sizes for pre-clinical, clinical, and post-launch studies, CE/IVD studies, and meta-analyses
  • Support R&D with statistical input and advise as needed for biomarker selection, algorithm development, and analytical studies
  • Write statistical analysis reports for various studies and regulatory submissions
  • Maintain proficiency in multiple statistical analysis and sample size software including nQuery, SAS, R, JMP, and Minitab
  • Stay current on product development issues and stages of clinical development by attending research review and development team meetings
  • Mentor junior/new biostatistics teammates in analysis of oncology studies.
  • Proactively communicate and protect the team & company's benefit
  • Consider the business needs in different clinical study design scenarios and educate the cross-functional team on how to improve prospects for future clinical studies
Job Requirements:
Qualifications:
  • Bachelors, Masters or Ph.D. degree in statistics or biostatistics
  • Minimum of 0 to 5+ years of related work experience (Bachelors: 5+ years; Masters: 3+ years; and PhD: 0-2 years)
  • Graduate-level knowledge of statistics including Survival Analysis, Logistic Regression, Multivariate Analysis, ANOVA, Categorical Data Analysis, and DOE
  • Must have excellent written and verbal communication skills
  • Must possess proficiency in statistical programming languages such as SAS and R.
  • Must have the ability to independently conduct MCMC simulations to test study designs and for sample size computations, when needed in complex or novel situations.
  • Must be a proactive learner and adapt to new statistical methods and statistical software that are useful in oncology development.
Preferred Qualifications:
  • In-depth understanding of Kaplan-Meier Analysis, the Cox PH Model, and the Mixed Model gained through both training and work experience is mandatory for this position
  • The Basic & Advanced SAS certifications are not required but preferred.
  • Past experience with CE-IVD and FDA (510(k) and PMA) submissions.
  • Past experience supporting the design and validation of multiplex qPCR biomarker panels.
  • Experience with analysis of real world / investigator-initiated study datasets, including meta-analyses of pooled datasets.
Physical Demands: Not specified

About Us
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we've taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at or follow us on Twitter
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