Principal Biostatistician

4 days ago

Bengaluru, India MUM Fortrea Development India Pvt Ltd 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.Fortrea is currently hiring Principal Biostatistician for the FSP team in India. Please find below the list of responsibilities.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

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.

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