Statistical Science Lead, Safety Statistician

Astellas Pharma • Northbrook, IL

119d • $150,000 - $195,000

About The Position

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Requirements

• PhD or M.S in Biostatistics, Statistics or related scientific field.
• 6+ years (9+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry.
• Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical and biomarker data.
• Knowledge and skills in SAS required, knowledge of R preferred.
• In-depth familiarity with processes and procedures in data management and programming.
• Experience working in an international environment.
• Experience in safety data analysis and risk management activities at the asset level.
• Good knowledge of medical literature, clinical, regulatory and commercial landscape.
• Ability to understand, implement, and explain complex statistical methodology.

Responsibilities

• Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs.
• Ensures quality and consistency of key safety data science deliverables.
• Accountable for the Asset Level Safety Assessment Plan (ALSAP).
• Independently provides strategic safety statistical input to the asset teams including design of studies and analyses requiring advanced statistical methodologies.
• Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose.
• Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results.
• Presents summary data and analyses to key stakeholders in a compelling and clear manner.
• Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
• May participate in due diligence activities, reviews safety data and advises company.
• Responsible to implement, explain and validate complex safety statistical methodology.
• Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value.
• Contributes to cross-functional or indication level improvement initiatives.
• Contributes to the recruitment, training, professional development and retention of statistical personnel.
• Is a member of external industry or professional organizations, developing relations with leading academic institutions.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees