Associate Director, Statistics

BioSpace; North Chicago (IL); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term and long-term incentive programs

Job summary

A leading pharmaceutical company is looking for an Associate Director of Statistics to manage statistical aspects of clinical development and life-cycle management. This role requires a strong background in statistics and experience in the pharmaceutical industry. Key responsibilities include leading regulatory submissions and collaborating across departments to drive innovative solutions. Exceptional communication and leadership skills are essential, along with a strong technical background in statistical methods.

Qualifications

• 10+ years of experience in Statistics or Biostatistics or 6+ years with a PhD.
• Knowledge of drug development processes in a regulated environment.
• High technical competence and ability to manage project timelines.
• Experience with regulatory submissions and product life-cycle management strategies.

Responsibilities

• Lead statistical aspects of clinical projects and regulatory submissions.
• Develop statistical analysis plans and protocols.
• Mentor and train junior statistical staff.
• Train and mentor staff; supervise junior statisticians.
• Develop data presentation strategy and collaborate on publications.
• Liaise with CROs and external collaborators on statistical issues.

Skills

Statistical concepts

Regulatory submission

Clinical trials

Data analysis

Communication skills

Communication

Education

MS in Statistics or Biostatistics

PhD in related field

Tools

Statistical software

Job description

Overview

Join to apply for the Associate Director, Statistics role at BioSpace

AbbVie is seeking a senior statistics professional to lead statistical aspects of clinical development and lifecycle management for assigned projects.

Job Description

The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients.

Responsibilities

• Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
• Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
• Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
• Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements.

Qualifications

As a qualified candidate, you should hold a MS with 10+ years of experience or a PhD with 6+ years of experience in Statistics, Biostatistics, or a highly related field.
Pharmaceutical or related industry knowledge is required, including experience and understanding of drug development and life-cycle management in the regulated environment.

You Should Also Possess

• A high degree of technical competence, as well as the ability to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
• The ability to manage project timeline and quality of deliverables
• The objective to drive innovation by continuously raising the bar and challenging the status quo
• Excellent communication skills, both oral and written
• The ability to build strong relationships with peers and cross-functional partners to achieve higher performance.
• Strong leadership skills and experience in working/managing cross-cultural or overseas teams

Key Stakeholders For This Role Include

• Clinical development experts
• Statistical programmers
• Data science experts
• (SSG) Patient safety experts
• (GMA Stat) Global Medical Affairs experts

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

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