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Principal Biostatistician, Infectious Disease/ Vaccines FSP (Hybrid role: Remote/ Boston, MA): #LI-REMOTE

Are you ready to discover your extraordinary potential at Labcorp Drug Development? A career here provides the unique chance to create a lasting impact and difference in patients’ lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative work place, along with access to comprehensive benefits. Your work is meaningful, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

We are seeking a Principal Biostatistician to lead large global or other major projects, analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients including tracking project activities and project time management. The selected candidate will provide statistical input into other disciplines’ activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes; supervise and train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Analysis Plans including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and mockups.

Essential Job Duties:

• Experience in observational research in Infectious diseases/ Vaccines (i.e. late phase).

• Can be Remote based but needs to be in office in Boston, MA for 1 week per month

• Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings

• Perform project management activities for identified projects including resource planning, timelines and milestone management

• Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants

• Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians

• Perform complex statistical analyses, quality check statistical analyses developed by other statisticians

• Conduct overall statistical review of TFLs for complex studies prior to client delivery

• Review CRF and other study specific specifications and plans - Perform complex sample size calculations under the supervision of more senior statistical staff

• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant

• Provide statistic input and review of the CSR for complex studies

• Preparation and review of randomization specifications and generation of randomization schedules

• Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures

• Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences

• Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business

• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives - Represent the department during audits.

Minimum Required:

• Recommended: Master’s degree, equivalent, or higher in Biostatistics or related field

• Required: Bachelor’s degree, equivalent, or higher in Biostatistics or related field

Minimum Required:

• 8+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job

• Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis

• Proven ability to effectively communicate statistical concepts

• A good knowledge of the overall clinical trial process and of its application within Covance Clinical Development Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials

US Pay Range: $130,000 - $170,000 USD

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here (https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf) .

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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