AbbVie
Director, Safety Statistics Group Oncology TA Head
AbbVie, South San Francisco, California, us, 94083
Director, Safety Statistics Group Oncology TA Head
Join to apply for the
Director, Safety Statistics Group Oncology TA Head
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AbbVie Director, Safety Statistics Group Oncology TA Head
10 hours ago Be among the first 25 applicants Join to apply for the
Director, Safety Statistics Group Oncology TA Head
role at
AbbVie This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$177,000.00/yr - $336,000.00/yr Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and Statistical Sciences (DSS). Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (e.g, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on products in the AbbVie portfolio ranging from early to later stages of development and life cycle management, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment.
AbbVie is seeking an experienced statistician to serve a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of statisticians in oncology.
This role will be based out of the North Chicago, IL or South San Francisco, CA AbbVie offices - 3 days in office.
Key Responsibilities:
Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs). Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP). Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies. Attend regulatory meetings. Oversight of the development of safety data integration specifications in accordance with analysis plan. Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses. Oversight of the development, delivery and interpretation of safety outputs, including graphics. Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines. Ensure appropriate interpretation of safety deliverables in collaboration with other functions. Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation. Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data. Stay current with industry trends and practices related to safety. Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on individual interests. Responsible for project and resource management within SSG for therapeutic area(s) of responsibility. Mentor team members and provide appropriate development opportunities.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in Statistics, Biostatistics. Minimum of 2 years of management experience required for people managers. Excellent communication skills, both oral and written Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience. In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues assoc/iated with scientific research trials, SOPs, etc.). Experience interacting with regulatory agencies. Experience in leading NDA, BLA, and or CTD submission preferred. Oversight of multiple safety-related projects (eg, ISS, benefit-risk assessment, signal detection).
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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, visit https://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
Seniority level Director Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AbbVie by 2x Sign in to set job alerts for “Safety Director” roles.
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Join to apply for the
Director, Safety Statistics Group Oncology TA Head
role at
AbbVie Director, Safety Statistics Group Oncology TA Head
10 hours ago Be among the first 25 applicants Join to apply for the
Director, Safety Statistics Group Oncology TA Head
role at
AbbVie This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$177,000.00/yr - $336,000.00/yr Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and Statistical Sciences (DSS). Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (e.g, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on products in the AbbVie portfolio ranging from early to later stages of development and life cycle management, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment.
AbbVie is seeking an experienced statistician to serve a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of statisticians in oncology.
This role will be based out of the North Chicago, IL or South San Francisco, CA AbbVie offices - 3 days in office.
Key Responsibilities:
Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs). Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP). Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies. Attend regulatory meetings. Oversight of the development of safety data integration specifications in accordance with analysis plan. Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses. Oversight of the development, delivery and interpretation of safety outputs, including graphics. Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines. Ensure appropriate interpretation of safety deliverables in collaboration with other functions. Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation. Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data. Stay current with industry trends and practices related to safety. Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics discipline (eg, ASA, PhUSE, DIA, etc.), depending on individual interests. Responsible for project and resource management within SSG for therapeutic area(s) of responsibility. Mentor team members and provide appropriate development opportunities.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in Statistics, Biostatistics. Minimum of 2 years of management experience required for people managers. Excellent communication skills, both oral and written Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience. In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues assoc/iated with scientific research trials, SOPs, etc.). Experience interacting with regulatory agencies. Experience in leading NDA, BLA, and or CTD submission preferred. Oversight of multiple safety-related projects (eg, ISS, benefit-risk assessment, signal detection).
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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, visit https://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
Seniority level Director Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AbbVie by 2x Sign in to set job alerts for “Safety Director” roles.
San Francisco, CA $150,000.00-$160,000.00 1 day ago South San Francisco, CA $140,000.00-$180,000.00 20 hours ago South San Francisco, CA $235,144.00-$290,472.00 1 month ago Global Director of Quality, Safety, Health, and Environment (QHSE)
Alameda, CA $180,000.00-$240,000.00 1 week ago Area Safety, Training and Compliance Manager
San Francisco, CA $75,000.00-$85,000.00 6 days ago San Francisco, CA $124,400.00-$291,600.00 7 months ago Safety Manager (or Director)- Heavy Civil
North Richmond, CA $130,000.00-$160,000.00 1 day ago Safety Manager (or Director)- Heavy Civil
San Rafael, CA $130,000.00-$160,000.00 1 day ago Director of Environmental Health and Safety (Manufacturing Experience Required)
Emeryville, CA $170,000.00-$220,000.00 1 day ago San Rafael, CA $140,000.00-$180,000.00 2 days ago Director, Acute Quality & Patient Safety (Clinician)
Head of Environmental Health and Safety (Manufacturing Experience Required)
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Chief Operating & Human Resources Officer
San Mateo, CA $150,000.00-$180,000.00 2 weeks ago Senior Medical Director, Patient Safety & Pharmacovigilance
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Fremont, CA $208,000.00-$265,000.00 2 days ago Director of Facilities & Fleet (Full-time w/ benefits)
San Francisco, CA $120,000.00-$125,000.00 3 months ago Director - Infection Prevention & Control
Oakland, CA $135,200.00-$140,000.00 15 hours ago Senior Director of Engineering, Accounts - Safety & Civility
San Mateo, CA $500,210.00-$546,060.00 1 week ago Oakland, CA $110,000.00-$120,000.00 20 hours ago Senior Medical Director, Patient Safety & Pharmacovigilance
South San Francisco, CA $287,292.00-$354,891.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr