Job Description

Responsibilities:
Under the supervision of the Biostats Sr. Manager, the Statistician will provide statistical support to product development projects (IVD assays, instruments and software) which includes evaluation of product design verification and design validation.
Statistician/Biostatistician will write and review statistical analysis plans for analytical and clinical validation studies and provide consultation and mentorship on statistical issues to R&D, Clinical Affairs, Regulatory Affairs, and Operations teams.
Individual will conduct data reviews, write reports, and present analyses and their interpretations to members of the R&D group. Associate will practice Design of Experiments from a statistical view-point (DOE), perform data analysis and provide interpretation. Other activities include building sample size determinations, performing calculations of clinical accuracy (PPA, NPA, PPV, NPV) and provide additional analysis requested for clinical trials and regulatory submissions.
Statistician/Biostatistician will include providing tables, line listings and multiple figures in accordance with protocols. As a member of the core team you will also participate in the review of study reports.
QC Analysis of another statistician
Write SAS code and contributes in development and validation of SAS Macros
Perform other analytical duties necessary.


Education:
BS Statistics/Biostatistics + 3 years of experience or MS + 1 year or PhD
Certifications in SAS programming a plus.


Experience:
Experience in data analysis with in-vitro diagnostics, medical devices, pharmaceutical, or life sciences.
Software experience includes the need for proficiency in programming (SAS and SAS Macros, R) and query of database systems (SQL).
Experience with analysis of sophisticated data from multiple sources and confirmed understanding of CLSI standards is a plus.
Experience and knowledge in Next-Generation Sequencing (NGS) is a plus.


Knowledge , Skills, Abilities:
A confirmed understanding of theory, experimental design and clinical trial methodologies, linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations.
Ability to work on multiple projects and programs independently and performing within project teams in a fast-paced environment
Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems.
Excellent communication skills (written and spoken) which include harmonizing with peers and distilling concepts into simpler terms are attributes which are highly valued.
Ability to flex your work schedule to accommodate multiple time zones is required.


Exact Shift - 8am-5pm, M-F, OT possible
Duration of assignment - 6months, possible extension.

Job Tags

Hourly pay, Flexible hours, Shift work,

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