Lead Biostatistician

The Lead Biostatistician within Fortrea is a client-facing, experienced biostatistician focused on building client trust through excellence in delivery across non-interventional and low-interventional studies as well as a broad spectrum of consulting areas (eg, health economics and outcomes research [HEOR]).

The Lead Biostatistician's main responsibilities include leading the development of biostatistical activities in client engagements, including research, planning, analysis, synthesis, and communication. This role contributes to the statistical credibility of Fortrea's study deliverables to regulators, payers, and HTA bodies - supporting study design and analytic execution across engagements under the direction of more senior-level RWE biostatisticians.

The Lead Biostatistician also actively supports internal process improvement initiatives and business development opportunities including proposal development, budgeting of biostatistical activities, and participating in bid defenses and capabilities presentations.

Summary of Responsibilities:

Business Development

• Supporting the pursuit of new and repeat business
• Strengthening key client relationships
• Contributing to the scoping and budgeting of relevant activities on opportunities

Practice & Company Initiatives

• Leading internal innovation initiatives to respond to the market's and client's needs
• Contributing to publications and conference presentations in area of expertise
• Applying and helping to improve Fortrea's non-interventional methods standards and best practices for study design, analytic reproducibility, and transparency

Client Delivery

• Addressing client's needs with appropriate study designs and statistical methods
• Leading the design and analysis of studies using real-world data (claims, EHR, registries, and linked/tokenized data), including target trial emulation and external/synthetic control arms
• Applying causal inference and confounding-control methods (eg, propensity score matching/weighting, IPW, instrumental variables, difference-in-differences, marginal structural models) with appropriate sensitivity and quantitative bias analyses
• Ensuring alignment with regulatory frameworks and data standards
• Authoring statistical analysis plans (SAPs), contributing to protocol design and estimand definition, and performing analytic quality control/reproducibility for engagement deliverables
• Managing project teams responsible for the relevant activities in the scope of work; advising and redirecting, as needed
• Delivering strategic, methodological, and conceptual expertise in client engagements
• Advising on relevant scientific or technical matters
• Communicating project findings to clients clearly and persuasively to scientific, regulatory, and payer audiences

People

• Contributing to cross-functional teams as needed for given projects
• Setting and maintaining a standard of personal behavior and business ethics in line with Fortrea culture
• Cultivating a positive environment and building positive connections with colleagues across Fortrea
• And all other duties as needed or assigned

Qualifications (Minimum Required):

• Graduate-level degree in discipline-relevant area (eg, biostatistics/statistics, economics, data science, epidemiology, health economics, pharmacy, medical)
• Demonstrated scientific and technical expertise in biostatistics
• Demonstrated success leading SAS programmers
• Successfully drafted client deliverables and maintained client relationships
• Strong interpersonal and communication (oral and written) skills
• Collaborative, cross-disciplinary team orientation

Experience (Minimum Required):

• At least 5 years of experience in biostatistics, including clinical study experience and drafting statistical analysis plans (or doctoral-level with at least 4 years)
• At least 2 years of experience managing project team SAS programmers for delivery of results

Preferred Qualifications Include:

• Doctoral level degree may be preferred, with scientific or technical knowledge and know-how in line with client expectations
• Strong business development, problem solving, and interpersonal skills
• Able to challenge conventional thinking to solve client issues and develop solutions
• Orientated towards working across related disciplines and teams to achieve client objectives
• Applied biostatistics to non-interventional and HEOR disciplines
• Understanding of CDISC standards
• Programming proficiency in SAS
  
  

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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