Team Lead, Statistical Programming, Oncology (Director)

Astellas Pharma • Northbrook, IL

4d • Hybrid

About The Position

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. This position has a dual purpose: manage 4+ direct reports and have a major influence on the leadership and technical capabilities of the department. The position can act as Global Statistical lead (GSTATL), Global Programmer Lead (GPROGL), Real World Data Scientist lead (RWDSL), Lead Product Statistician (LPS), Statistical Biomarker Lead (SBL) or as a Regional/site Head. With no or minimal experience as people manager and an extensive knowledge of the scientific and regulatory area of responsibility and experience in multiple indications; the position is expected to ask critical scientific questions, challenge hypotheses, designs and results interpretation. The position is responsible for the optimal development and assignments of reports (all individual contributors; Statistical Science Lead, Statistician, Statistical programming Lead, Programmer and RWD scientist) to Astellas asset teams, study teams or deliverables teams (e.g. IEGP, EDAP) for the assigned projects. The position supports Senior management with decision making at the asset and portfolio level with an impact within and outside of the organization. The position works independently and involves the right level of participants as needed effectively engaged as a matrix team member in M&D. This position represents Astellas on statistical matters related to clinical data, RWD, Biomarkers PROs, PK/PD analysis or methodology at meetings with regulatory authorities, key opinion leaders and HTAs.

Requirements

• Bachelor’s or master’s in statistics, mathematics, or related field
• 12+ years (15+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry and working with vendors
• 8+ years’ experience as a lead programmer working on global clinical studies and projects or global process and system initiatives
• 5+ years’ experience in mentoring/leading statistical programmers
• Prior working experience with Oncology
• Prior experiencing leading a team

Responsibilities

• Accountable for multiple projects, challenging and assessing the asset strategy and ensuring the statistical/scientific soundness of all input and deliverables for the assigned projects.
• Works on the most complex and critical projects from pre–Candidate Nomination (CN) till life cycle management impacting CN, Proof of Concept, approval and post submission strategies.
• Advises asset teams on challenging statistical/epidemiological design, analysis and decision-making issues for interventional and non-interventional studies.
• Advises on how RWD and Clinical Trial post hoc analyses can support drug development, Pricing submissions and the Growth strategy in general.
• Advises on how omics and biomarkers can support drug development and the BOLD objectives.
• Advises on how programming support will be executed for all stakeholders’ needs globally.
• Performs/supervises modeling and simulations, leverages external experts to provide input to clinical development issues.
• Provides oversight on statistical/scientific/programming matters for meetings with regulatory authorities, HTAs, key opinion leaders and similar experts.
• Reviews key project level documents.
• Participates in due diligence activities, external initiatives or working groups.
• Presents and defends complex solutions to governance committees (KACHI, PRC, MA-C, EC), key stakeholders, or regulatory bodies in a compelling and impactful way.
• Stays at the cutting edge of methodology development in statistics, epidemiology, regulatory and HTA guidelines, and industry trends in drug development, particularly with respect to the Primary Focus of interest, and signals relevant developments in a timely manner for the company.
• Ensures efficient and innovative ways of programming are selected for each deliverable.
• Researches, creates, validates, implements and teaches complex methodologies ensuring the department stays at the forefront of innovational drug development.
• Supervision (first line manager) of 4+ direct reports.
• Assist with recruitment, development / career management and retention of staff.
• Oversees adherence to timelines, standards, processes for work assigned to their members of staff.
• Responsible for compliance of direct reports with Astellas policies and procedures.
• Challenges and influences peers and senior managers inside and outside of Quantitative Sciences and Evidence Generation (QSEG) on best practice in their area of competence.
• As a leader, member of external industry or professional organizations, develops and maintains relationships with peers and key leaders. Actively participates in professional association activities to support the branding of Astellas.
• Understands Astellas’ priorities, uses position to advance Astellas’ mission through high quality statistical programming work - ensures programming team stays current with changes in regulatory requirements globally.
• Contributes in ensuring that Astellas is at the forefront of recruitment, training, professional development and retention of statistical programming personnel.
• Partners with SRS LT to set short- and long-term strategic direction for programming function.
• Partners with programming team in other Astellas sites to ensure global consistency, global efficient resource utilization and development.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 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
• Company fleet vehicle for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Director