Principal Biostatistics - Mumbai, India - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Mumbai, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects. Contributes to study proposals and bids, representing the department at bid defenses.

Oversees the resourcing of program of studies, or integrated summaries, develops and implements strategies to ensure optimal efficiencies around process, programming and client needs.

Provides support, guidance and project leadership to junior and senior team members. Provides oversight for strategic client relationships, and/or oversight for significant client portfolios.

Serves as (or mentors/coordinates staff in the roles of) lead statistician, project lead, senior reviewer, or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.

Serves as (or mentors others in the role of) the randomization statistician on selected projects.
Prepares and reviews statistical reports, (or mentors others in the role of) clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports.
Manages resourcing and delivery strategy of complex books of work ISS/ISE, submissions etc

Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Conducts training and implementation of new procedures and new industry knowledge.

Participates in strategic client franchise leadership.
Provides mentorship and guidance to junior team members; assists people managers with leadership activities, such as interviewing, job description design, etc.

Master degree in statistics, biostatistics, mathematics or related field with 8+ years' experience.

Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years'). Master's degree in statistics, biostatistics, mathematics or related field

Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Demonstrated initiative and motivation
Capable of leading complex projects

Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff

Strong verbal and written communication skills
Positive attitude and the ability to proactively direct and promote teamwork in a multidisciplinary team setting
Indepth knowledge of SAS and clinical biostatistics
Indepth understanding of the drug development process and FDA regulations
Capable of managing change and uncertainty to optimize positive outcomes