{Job Title : Remote Statistician/Biostatistician (Medical devices manufacturing)}
Pay Range:
{$45/hr-$45/hr}
Position Type:
{Full time, Contract}
Location:
{Remote}
Onsite Flexibility:
{All Remote}
(Ability to flex your work schedule to accommodate multiple time zones is required.)
Job Description
Exact Shift - 8am-5pm, M-F, OT possible
Duration of assignment - 6months, possible extension.
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.
• Associate 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,
Qualifications:
Education:
• BS Statistics (or related field) + 1 year of experience or MS/PhD in Statistics (or related field).
• 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.
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 Client problems.
• Excellent communication skills (written and spoken) which include harmonizing with peers and distilling concepts into simpler terms are attributes which are highly valued.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
- Four options of medical Insurance
- Dental and Vision Insurance
- 401k Contributions
- Critical Illness Insurance
- Voluntary Permanent Life Insurance
- Accident Insurance
- Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Want to read more about LanceSoft?
Click here to visit our website - www.lancesoft.com
