- Protocols: Provide study design, calculate sample-size, develop randomization specifications and write statistical analysis plans to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Implement randomization schedules as planned with Interactive Response Technology vendor, Global Drug Supply Management, and other partners.
- Database Activities: Assist in identifying scientifically appropriate data collection instruments. Ensure data collection is free of bias. Provide programming specifications for derived variables and analysis datasets. Assist with development and implementation of project-specific data standards. Identify and report data issues or violation of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis.
- Statistical Analyses: Explain statistical concepts to non-statisticians. Develop analysis plans ensuring statistical methods are appropriate with the study design with detail for programming. Ensures internal consistency of analysis plans. Perform statistical analyses per the SAP. Independently anticipate need and implement complex statistical methodology. Evaluate available statistical methodology and software and the need for novel statistical methodology.
- Reports and Publications: With project team, develop strategy for data presentation and inference. With supervision, write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures.
- Consultation: Work collaboratively with multi-function teams per agreed timelines. Timely inform management on important issues that may arise. Provide responses to questions from clients and independently pursue analyses suggested by data. Effectively and persuasively present statistical concepts, evidence and assessment of risks and impact. Communicate a basic understanding of scientific and regulatory principles for assigned projects.
- External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations. Communicate with statisticians outside PCYC concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department.
- Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own research or review of literature at meetings. Participate in departmental activities including recruiting, training/mentoring, research efforts and cross-functional collaborations, as needed.
- Regulatory Activities: Participate with department management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies.
- Compliance: Compliant with applicable corporate and divisional policies, procedures, and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to the Statistics function. Maintain department standards, GxP compliance, and best operating practices. Complete all assigned training on time.
Qualifications - MS (with 6+ years of experience) or PhD (with 2+ years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and effective communication skills, both oral and written
- Able to perform statistical computations and simulations.
- Able to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- Able to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
- Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.
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 believesingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, and we mayultimatelypay 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/visioninsurance 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 payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensationand benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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Manager, Statistics - South San Francisco, United States - AbbVie
Description
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose:
The Manager, Statistics provides statistical expertise to support the research and development organization. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.
Responsibilities:
