06/03/2025) Manager Biostatistics

3 weeks ago

Mysore, Karnataka, India Syneos Health Full time

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong. Job responsibilities Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. Supports the assignment of or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. May be responsible for leading or participating in projects across multiple studies or programs. May support business development activities. May participate in or lead departmental or corporate initiatives. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications What we're looking for Graduate degree, or equivalent, in biostatistics or related discipline. Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. Previous management experience or demonstrated leadership ability preferred. Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. Experience with regulatory submissions preferred. Ability to read, write, speak, and understand English. Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade.

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