Biostatistician IV (100 REMOTE)

Description:

The Biostatistician IV provides study- and project-level statistical support for clinical studies in assuring appropriate design, analysis and interpretation of results, and contributing to regulatory submissions and negotiations.

Perform independently as a Project Statistician for routine projects or projects with BI experience.
Provide statistical support for research and development Clinical studies at the study and project level, & in compliance with BI/regulatory guidelines, including:

• Contribute to design of Clinical studies of increasing complexity in alignment with appropriate statistical methodology, project objectives and regulatory standards, conforming to R&D, marketing and/or publication strategies.
• Manage study parameters to provide efficient, effective and optimally-sized studies which will provide sufficient data for regulatory submissions.
• Prepare/review reports for clinical trials of moderate complexity for registration of drugs and biologics... publications and management to ensure appropriate analyses and interpretation of results.

Evaluate alternative experimental designs, analysis methods, and statistical theory as relevant to BIAH projects. Pursue and apply industry innovations and comply with shifts in regulatory landscape. Participate in internal or external working groups.

Provide statistical expertise to the Biostatistics group regarding technical, scientific, or industry-related topics that could be applied for more efficient and effective use of resources. Align proactively with global colleagues where appropriate.

Comply with company SOPs and relevant regulatory guidances at national and international levels. Act at all times within industry, company, and statistical standards and ethics Apply solid understanding of relevant regulations governing the Animal Health industry.

Skills:
The incumbent must:

• Balance and prioritize project work according to business objectives.
• Ensure work is compliant with applicable regulatory requirements which vary by geographic region and agency.
• Interact with counterparts in other divisions and regions.
• Research, justify, and apply innovative approaches when needed to analyze complex data or solve problems.

They will participate on project and clinical study teams, independently representing Biostatistics group perspectives. They will contribute to Biostatistics group positions, meet and negotiate with members of other functions to guide study design, ensure compliance and accurately interpret and report statistical principles and analysis results; will also contribute statistical expertise in other areas as Company business needs require.

Consistently applies a solid foundation of statistical scientific/technical knowledge; exhibits strong communications skills, accepts guidance, and demonstrates motivation for contribution, independent work, learning and development.

highly desirable, preferably including clinical trial design and analysis in the pharmaceutical/biological industry.

Expertise in particular scientific disciplines related to animal health or pharmaceutical/biological industry is highly desirable.

Required software proficiency: SAS, R, MS Office applications. In particular, demonstrated ability in SAS programming and R, supporting the analysis of data using linear mixed models, generalized linear mixed models, survival and categorical methods.

Knowledge of statistical theory and application of statistical methodologies in study design and data analysis is required.

Solid understanding of applicable regulations governing the Animal Health industry.

Experience reflecting ability to

• Conduct power calculations, assess experimental designs, conduct analyses, and provide interpretation of results.
• Work successfully in a team environment to accomplish goals.
• Communicate statistical information to non-statisticians
• Work independently and with other Biostatisticians to determine appropriate statistical analysis methods and efficient experimental designs to address project objectives.
• Manage multiple tasks with differing priorities to meet time lines.
• Negotiate among multiple parties to find mutually reasonable outcomes.
• Interact with regulatory authorities on statistical issues at the project level.
• Manage project(s) from a statistical perspective.
• Work with researchers in determining the most effective and efficient designs to address project objectives

Education:
.Doctoral (preferred) or Masters degree in Statistics/Biostatistics

Recommended 5 (Doctoral) / 9 (Masters) years of industry or relevant experience

Experience in the pharmaceutical, animal health, or agricultural science industry is highly desirable, preferably including clinical trial design and analysis in the pharmaceutical/biological industry.

Note: This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.

Pay range: $178- $187 per hour negotiable based on experience and skills

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require a reasonable accommodation.

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