Gore Medical

About the Role: The Clinical Biostatistics Functional Team Leader leads a team of Biostatistics Associates with responsibilities primarily focused on providing high quality statistical support of clinical investigations, clinical operations, and other cross-functional initiatives aligned with the functional and divisional objectives. This role will provide sound statistical guidance and oversight of the biostatistics function relating to statistical practices, standards, and regulatory expectations. This role requires strong leadership skills, knowledge of regulatory requirements, and a deep understanding of biostatistics. 

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities: 

• Provide primary Leadership to Biostatistics Associates; lead and manage a team of individuals, providing clear direction, setting performance expectations, and ensuring accountability for results; delegate tasks and responsibilities appropriately, considering team members' strengths and development areas; foster teamwork and collaboration, promoting a supportive and inclusive culture within the team
• Identify the unique strengths, talents, and development needs of each team member; provide regular feedback and constructive guidance to enhance individual and team performance; mentor and support team members in their professional growth, helping them set goals and create development plans
• Set challenging yet attainable goals for the team, aligned with the organization's objectives and in accordance with any changing external standards or regulatory requirements; monitor and evaluate individual and team performance, providing timely recognition and addressing performance gaps; conduct performance reviews and facilitate career conversations to support Associate’s growth
• Establish core competencies for the Biostatistics function; identify the training and development needs of the team and coordinate appropriate learning opportunities; arrange or facilitate training sessions, workshops, or other developmental activities to enhance team members' skills and knowledge; encourage a culture of continuous learning within the team, promoting the sharing of best practices and knowledge exchange
• Address conflicts or issues within the team promptly and objectively, promoting open communication and resolution; mediate and facilitate constructive dialogue to promote understanding and collaboration; implement strategies to prevent or mitigate future conflicts
• Lead by example, demonstrating professionalism, integrity, and a strong work ethic; communicate effectively with team members, ensuring clarity of objectives, expectations, and performance standards; foster a culture of open communication, actively listening to team members' concerns and providing guidance and support as needed
• Identify opportunities for process improvement and increased efficiency within the team; encourage innovative thinking and creative problem-solving among team members; regularly review team processes and workflows, implementing changes to optimize performance and outcome
• Utilize expertise to provide statistical guidance and oversight to clinical study teams, clinical operations, and other cross-functional teams supporting clinical and divisional objectives
• Drive strategic planning activities for the biostatistics functional team and participate in planning for the Clinical Affairs organization as a whole
• Utilize subject matter expertise and contribute to the establishment of best practices worldwide, including identification of gaps, development of processes and SOPs, and incorporation of regulatory and industry changes on an ongoing basis

Required Qualifications: 

• Masters degree
• Minimum 5 years of experience in a statistical role or clinical study development role with minimum 2 years of experience in Health Sciences, Pharma, Biotech, or Medical Device Research
• Experience working successfully on project teams with demonstrated leadership skills 
• Collaborative and consultative decision-making style
• Strong organizational skills, flexibility, and ability to multi-task
• Strong verbal and written communication skills 
• Ability to travel up to 10%

Desired Qualifications:

• Advanced degree (Masters or PhD) in biostatistics or statistics-related field
• Minimum 2 years of demonstrated experience with leadership of people, strategy, and processes
• Experience addressing statistical queries from regulatory agencies

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. 

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. 

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact