Manager, Statistical Programming
2 weeks ago
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.
Responsibilities:
Participates in proposal development for standalone, small programs and/or new drug applications (NDAs) and in bid defense. Actively monitors staff projects quality, timelines, and budgets to foresee and correct issues and assure project expectations are met. Manages discretionary expenses and spending within team in order to meet budget. Work closely with leads to ensure that staff resources are used efficiently, and team is well utilized. Manages resources within team: new hires, terminations, transfers, and contractors. Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures, and administrative activities. Helps encourage staff career growth and development. Provides statistical programming support and technical support to team members. Act as the lead programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, ISS and ISE, and electronic submissions. Participates in internal and client audits, and regulatory inspections. Proactively lead, review, and amend departmental processes and documentation. Facilitate advanced technical expertise, share knowledge at department meetings. Keeps abreast of new statistical programming practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growthQualifications (Minimum Required):
Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects. Experience and/or education plus relevant work experience, equating to a Bachelor's degree.Experience (Minimum Required):
Minimum 10 years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job. Extensive experience and proven skills in the use of SAS® programs within a clinical trials environment including all processes/practices used with a Statistical Programming environment. Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management. Strong supervisory skills, and ability to organize their own and others' work. Strong problem-solving skills, and a willingness to take ownership of decision-making.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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bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs 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...
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bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs 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...
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bangalore, India Fortrea Full timeAs 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...
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Bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs 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...
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