Principal Biostatistician

7 days ago

Bengaluru, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

What to expect:

- 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 analysis, quality check statistical analyses developed by other statisticians
- Conduct overall statistical review of TLFs for complex studies prior to client delivery
- Review of CRF and other stud specific documents 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 statistical 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 department 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.

Educational qualification:

- M.Sc Statistics
- M.Phill Statistics
- Ph.D Statistics

**Experience**:

- 7-12 years

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?

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.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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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