Biostatistician

Job Description

We are seeking a talented and motivated Biostatistician to provide statistical support to product development projects, including the evaluation of product design verification and validation. This role involves writing and reviewing statistical analysis plans, conducting data reviews, and presenting analyses to the R&D group. The Biostatistician will practice Design of Experiments (DOE), perform data analysis, and contribute to clinical trials and regulatory submissions.

Responsibilities

• Provide statistical support to product development projects (IVD assays, instruments, and software).
• Write and review statistical analysis plans for analytical and clinical validation studies.
• Offer consultation and mentorship on statistical issues to R&D, Clinical Affairs, Regulatory Affairs, and Operations teams.
• Conduct data reviews, write reports, and present analyses and interpretations to the R&D group.
• Practice Design of Experiments (DOE) and perform data analysis and interpretation.
• Build sample size determinations and perform calculations of clinical accuracy (PPA, NPA, PPV, NPV).
• Provide additional analysis for clinical trials and regulatory submissions.
• Provide tables, line listings, and figures in accordance with protocols.
• Participate in the review of study reports as a core team member.
• Quality control analysis of another statistician's work.
• Write SAS code and contribute to the development and validation of statistical software.
• Perform other analytical duties as necessary.

Essential Skills

• BS in Statistics (or related field) with 1 year of experience, or MS/PhD in Statistics (or related field).
• Experience in data analysis with in-vitro diagnostics, medical devices, pharmaceuticals, or life sciences.
• Proficiency in programming (SAS and R) and querying database systems (SQL).
• Knowledge of theory, experimental design, and clinical trial methodologies.
• Understanding of linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations.
• Ability to work on multiple projects independently and within project teams in a fast-paced environment.
• Excellent written and spoken communication skills.
• Ability to flex work schedule to accommodate multiple time zones.
• Certifications in SAS programming.
• Experience with analysis of sophisticated data from multiple sources.
• Understanding of CLSI standards.

Work Environment

This is a fully remote position with standard working hours from 8am to 5pm, Monday to Friday. The role offers the opportunity to work in a dynamic, rapidly growing biotech company that values creativity, innovation, and science. The position includes a competitive salary with extensive benefits and the potential for assignment extension.

Pay and Benefits

The pay range for this position is $35.00 - $45.00/hr.

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $35 - $45