BioSpace
Overview
Associate Director, Statistics - (Hybrid) role at BioSpace. The Associate Director provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas may include clinical trials, patient safety, and global medical affairs. The role works in partnership with experts in multiple disciplines to advance medicines to patients. Company: AbbVie (Allergan Aesthetics portfolio). For more information about AbbVie, please visit us at www.abbvie.com. Responsibilities
Provide expertise and leadership for regulatory submission and product life-cycle management strategy planning and implementation. Lead design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated safety analysis plans/analysis plans for evidence generation). Represent the function on project teams to provide statistical input to development and align with functional management. Partner with Clinical, Regulatory, Patient Safety, or GMA to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodologies. Propose novel statistical approaches for study design. Provide sufficient detail for programming implementation. Ensure that all analyses in protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Support recruitment and professional development of staff. Develop strategy for data presentation and inference. Ensure interpretation of statistical deliverables in collaboration with other functions. Collaborate on publications of scientific research. Ensure accuracy and internal consistency of reports and publications (tables, listings, figures). Act as liaison for statistical issues onAbbVie collaborative studies with CROs, academic institutions, government agencies, steering/data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections to promote the statistics department. (Clinical Statistics) Ensure regulatory requirements are met for work processes. Review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software for SOP and regulatory compliance. Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or related field High degree of technical competence and excellent communication skills (oral and written) Ability to identify data or analytical issues and provide solutions with own skills or by seeking help Ability to manage project timelines and deliverables of high quality Ability to build strong relationships with peers and cross-functional partners; motivated to drive innovation Strong leadership skills and experience managing cross-cultural or overseas teams Pharmaceutical or related industry knowledge in drug development and lifecycle management in a regulated environment Additional Information
The compensation range described is the range of possible base pay compensation the Company believes in good faith it will pay for this role at posting time; individual compensation depends on factors including geographic location and may be modified in the future. Comprehensive benefits include paid time off, medical/dental/vision insurance and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested and determinable. The amount and availability of any bonus, commission, incentive, benefits, or other compensation remains at the sole discretion of the Company unless paid and may be modified. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Internet News New job opportunities and salary ranges for related roles are listed to provide context about the market. Referrals increase your chances of interviewing at BioSpace. Get notified about new Director of Analytics jobs in Florham Park, NJ.
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Associate Director, Statistics - (Hybrid) role at BioSpace. The Associate Director provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas may include clinical trials, patient safety, and global medical affairs. The role works in partnership with experts in multiple disciplines to advance medicines to patients. Company: AbbVie (Allergan Aesthetics portfolio). For more information about AbbVie, please visit us at www.abbvie.com. Responsibilities
Provide expertise and leadership for regulatory submission and product life-cycle management strategy planning and implementation. Lead design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated safety analysis plans/analysis plans for evidence generation). Represent the function on project teams to provide statistical input to development and align with functional management. Partner with Clinical, Regulatory, Patient Safety, or GMA to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodologies. Propose novel statistical approaches for study design. Provide sufficient detail for programming implementation. Ensure that all analyses in protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Support recruitment and professional development of staff. Develop strategy for data presentation and inference. Ensure interpretation of statistical deliverables in collaboration with other functions. Collaborate on publications of scientific research. Ensure accuracy and internal consistency of reports and publications (tables, listings, figures). Act as liaison for statistical issues onAbbVie collaborative studies with CROs, academic institutions, government agencies, steering/data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections to promote the statistics department. (Clinical Statistics) Ensure regulatory requirements are met for work processes. Review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software for SOP and regulatory compliance. Qualifications
MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or related field High degree of technical competence and excellent communication skills (oral and written) Ability to identify data or analytical issues and provide solutions with own skills or by seeking help Ability to manage project timelines and deliverables of high quality Ability to build strong relationships with peers and cross-functional partners; motivated to drive innovation Strong leadership skills and experience managing cross-cultural or overseas teams Pharmaceutical or related industry knowledge in drug development and lifecycle management in a regulated environment Additional Information
The compensation range described is the range of possible base pay compensation the Company believes in good faith it will pay for this role at posting time; individual compensation depends on factors including geographic location and may be modified in the future. Comprehensive benefits include paid time off, medical/dental/vision insurance and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested and determinable. The amount and availability of any bonus, commission, incentive, benefits, or other compensation remains at the sole discretion of the Company unless paid and may be modified. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Internet News New job opportunities and salary ranges for related roles are listed to provide context about the market. Referrals increase your chances of interviewing at BioSpace. Get notified about new Director of Analytics jobs in Florham Park, NJ.
#J-18808-Ljbffr