Director, Statistical Programmer

Company Information

Imagine your child scratching herself so unstoppably through the night that she wakes with blood-stained sheets. Nothing soothes her. You haven’t slept through the night in years. At school, unable to focus, she takes off her shoes and socks to scratch her feet on the carpet. The itch is inescapable. She has a life-threatening liver disease, and it’s getting worse.

Now imagine that you work for a company with a chance to help this child and her family.

This is Albireo. We are relentlessly focused on liver disease with the belief that bile acid modulation offers an innovative way to treat numerous rare and more common diseases affecting people worldwide. We are building a collaborative, committed, employee-friendly company, as we work to make this vision a reality.

Albireo is a public clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat rare childhood liver disease and other liver or gastrointestinal diseases and disorders. Albireo has deep expertise in bile acid biology and a clinical pipeline of three mid to late-stage product candidates designed to act locally to restore normal bile acid levels and treat diseases associated with irregularities in bile acid biology.

Albireo’s lead program is developing a therapy to treat patients with Progressive Familial Intrahepatic Cholestasis (PFIC). The Company initiated its global phase 3 study of A4250 in patients with PFIC in 2018 and expects topline results in mid-2020, with a projected potential first regulatory approval and launch in 2021.

Albireo was spun out from AstraZeneca in 2008 and is led by Ron Cooper, Albireo’s first President & CEO. Ron Cooper is a global P&L leader who joined Albireo after a distinguished career at Bristol Myers Squibb, including serving as BMS’s President of Europe, where he was responsible for 30 countries and sales exceeding $4.5B.

Albireo is located in Boston, Massachusetts (Financial District), and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden.

Job Description

Job Title:         Director, Statistical Programming Leader

Reports To:      Sr. Direcor of Biostatistics and Programming, Biometrics Department

Location:           Boston, MA

Position Summary:

Reporting to Sr. Direcor of Biostatistics and Programming from the Biometrics Department, Statistical Programming Director within the Biometrics Department is expected to be a highly experienced functional area project and people leader with expert knowledge of Statistical Programming strategy, concepts and processes, excellent people leadership skills and capabilities in overseeing Statistical Programming activities and teams within the Statistical Programming and Analysis functional area in accordance to company and departmental processes and procedures.

In Collaboration with senior departmental leadership, the statisticsl programming Director influences departmental effectiveness acting as a change agent to drive and implement the Statistical Programming and Analysis strategic vision.

Key Duties and Responsibilities:

  • Accountable for the strategy, planning and execution of Statistical Programming and Analysis activities and deliverables across a portfolio of one or more programs of medium to high complexity for multiple therapeutic areas.
  • Serves as a statistical programming expert and influencer on internal and external (industry) work groups.
  • Responsible for the planning, execution and completion of all statistical programming activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned programs.
  • In collaboration with functional leadership, designs statistical programming strategy across assigned portfolio over the life cycle of a compound / program to ensure consistency, efficiency and quality of statistical programming deliverables.
  • In collaboration with the Statistical lead and other cross functional colleagues, provides input to submission strategy to regulatory agencies and ensures all statistical programming related deliverables are complete and compliant, including but not limited to those supporting regulatory/health authority requests for information and data disclosure.
  • Responsible for implementation of data and statistical programming standards, including data life cycle plans ensuring consistency in analysis dataset design across trials, within a program.
  • Serves as the statistical programming primary point of contact for a given program or across various programs and studies, representing the Statistical Programming and Analysis function on the clinical team for cross-trial activities as needed.
  • Contributes to the development and oversight of Statistical Programming and Analysis vendor contracts and R&D company business planning budget estimates. Oversees vendor management and escalation for projects within assigned portfolio.
  • Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
  • Responsible for anticipation, early detection, prevention and management of risks and issues impacting statistical programming deliverables. Effectively manages program level statistical programming issue resolution activities, adopting appropriate escalation pathways as needed. Participates in project or trial initiation activities, as needed.
  • Collaborates with external partners on statistical programming related activities and deliverables for co-development programs.
  • Takes a leadership role for statistical programming related aspects of regulatory agency inspections and Albireo internal audits. Coordinates and ensures real time inspection readiness for all statistical programming deliverables as necessary.
  • Responsible for performance management and supports the development of assigned personnel through effective feedback, coaching, functional and disease area training and identifying appropriate development opportunities. Reporting line may include managers in addition to individual contributors.
  • Ensures compliance of assigned teams and personnel with company and department SOP’s, policies and regulatory guidance documents.
  • Contributes to or leads the development and maintenance of departmental policies, procedures, training and standards.
  • Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department. Stays current with industry trends and policies that have an effect on departmental processes.
  • Serves as departmental resource in areas of process and technical expertise. Contributes to and may lead departmental innovation and process improvement projects within the Statistical Programming and Analysis functional area and, as required, may contribute statistical programming expertise to cross functional projects/initiatives.
  • Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
  • Responsible for local administration and decision making associated with the management of assigned personnel, including recruitment/hiring, onboarding, performance management, budget, travel, etc.

Qualifications:

  • Bachelor’s or advanced degree (Masters, PhD) and/or equivalent in computer science, mathematics, or other relevant scientific field e.g. Biology/Pharmacology (or equivalent theoretical/technical depth).
  • Approximately 12+ years programming experience with increasing responsibility OR Masters (or equivalent) in a relevant field and 10+ years relevant experience in a pharmaceutical/ clinical trial environment.
  • In-depth knowledge of programming practices and concepts (including tools, languages and processes) and relevant regulatory guidelines policies.
  • Demonstrated experience planning and coordinating complex programming strategy and delivery, and managing and overseeing statistical programming activities, or equivalent where therapeutic/disease area and portfolio knowledge is required
  • Demonstrated people management skills and experience in staff performance management and people development.
  • Demonstrated experience managing resources and leading teams to successful outcomes.
  • Demonstrated project and risk management skills.
  • Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers.
  • Excellent leadership, influencing and decision-making skills, and proven ability to foster team productivity and cohesiveness, acting as a change agent, and adapting to rapidly changing organization and business environments.
  • Demonstrated experience managing the outsourcing or externalization of statistical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions).
  • Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies.
  • Demonstrated experience with SAS or R
  • Demonstrated experience developing and supporting the implementation of innovative technical solutions to enhance efficiency and/or quality.
  • In depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. NDA/MAA/BLA submission experience required.
  • Ability to lead and manage vendor partnerships, strong negotiation skills and ability to close offers through diplomacy, and strong interpersonal and communication skills.

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.