Role Description We are seeking a Senior/Principal level biostatistician to fill a post-submission and RWE role with a major client. This individual should be an experienced/veteran statistician in the healthcare industry and looking to take on a leadership role in such an environment. - Join our FSP department and work for one of the top pharmaceutical companies. - Lead post submission evidence generation using CDISC datasets, Claims, and raw biological data. - Bring mature computational, operational and production experience. Qualifications - Experienced/veteran statistician in the healthcare industry. - Leadership experience in a biostatistics role. Requirements - Expertise in post-submission and RWE processes. - Proficient in handling CDISC datasets, Claims, and raw biological data. Benefits - Significant professional growth opportunities. - Collaborative work environment focused on advancing drug development.

Title: Associate Director, HEOR, Patient-Centered Research Location: Remote - US or Hybrid - Cambridge, MA Job Code2399 # of openings: 1 Job Description: Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director, HEOR, Patient Centered Research to join our growing HEOR team who will lead Patient-Centered Research activities across all GDD programs, including but not limited to pyruvate kinase deficiency, thalassemia, and sickle cell disease. The HEOR team at Agios focuses on three pillars of activities: - Clinical development program support (e.g. patient-reported outcomes [PRO] strategies for clinical trials); - Real-world evidence generation (e.g. studies of natural history, burden of illness, treatment patterns, etc. using a variety of data sources including EMR, claims data, registries, chart reviews, and qualitative research); and, - Market access support (e.g. cost-effectiveness and budget impact modeling, AMCP and global value dossiers). We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Associate Director, HEOR will be largely focused on clinical development program support and PRO-related real-world evidence generation activities. They are expected to have expertise in clinical outcomes assessment (COA) strategy and analysis (including PROs) and strong qualitative research skills. They will be accountable for designing and conducting superior quality research that is medically relevant, scientifically valid, and aligned with the evidence generation and communication needs of our programs. This role will report to the Senior Director of Health Economics & Outcomes Research within Global Medical Affairs. What you will do: - Design and execution of quantitative and qualitative research (including PROs, preference studies, patient interviews, etc) to incorporate patient perspectives into clinical research and real-world evidence studies across the product lifecycle to support regulatory approval, product labeling, value demonstration, and market access activities; - Understanding patient insights and experiences with disease and treatment, through the measurement of outcomes that matter most to patients, including symptoms of disease, effects of treatment, and their impact on how patients feel and function; - Execution of gap analyses, patient interviews, and/or reviews of the literature and PRO labels, to select and/or develop appropriate patient-reported measures or other COAs for clinical trials in accordance with FDA and EMA guidance; - Collaboration with cross-functional partners on COA endpoint strategy; - Leading the preparation of the COA components of regulatory briefing books, clinical trial protocols, statistical analysis plans, clinical study reports, regulatory filing documents, and HTA submissions; - Collaboration with study statisticians on the analysis and interpretation of COA data, including assessments of clinically meaningful change; - Development and execution of publication plans (abstract, posters, and manuscripts) and preparation of internal and external-facing presentations of patient-centered research findings; - Ad hoc support of HEOR indication leads with real-word evidence generation activities such as natural history, burden of illness, treatment patterns, or other outcomes research studies; - Management of relationships and budgets with vendors to ensure timely completion of high quality projects; - Building strong relationships with internal partners and ensuring continuous and consistent communication regarding HEOR projects; - Compliance with all applicable laws, Agios policies, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners. What you bring: - Master's or doctoral degree in health services research, sociology, psychology, psychometrics, public health, or related field; - At least 7 years of pharmaceutical/biotechnology industry, consulting, or academic experience, at least 5 years of which has been specifically focused on patient-centered research; - Demonstrated technical and strategic excellence in designing, conducting, and interpreting quantitative and qualitative patient-centered research; - Knowledge of the drug development process, PRO label claims, and regulatory guidance as it relates to patient-centered research, including the FDA's patient-focused drug development (PFDD) initiative; - Strong knowledge of the process for developing and validating outcome measures, methods for determination of clinically meaningful change thresholds, and clinical trial endpoint strategy; - Ability to lead multiple projects simultaneously across a variety of therapeutic areas; - Excellent written and oral communication skills; - Strong interpersonal skills and ability to collaborate on cross-functional teams; - Ability to interface with multiple external stakeholders, including patients, caregivers, clinicians, regulators, and payers; - Ability to navigate ambiguous, complex, and difficult situations; - Ability to travel approximately 10% of the time Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is based on employees individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. What we will give you: - Deliberate Development. Your professional growth as one of our top priorities. - Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. - Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. - Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. - Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries. - Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce. - Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

• Act as an extension of the client’s global study team to ensure operational perfection in clinical study management across all phases and therapeutic areas. • Ensure the integrity of trial coordination activities - data eTMF oversight ensuring inspection readiness, vendor management, CRO oversight and project planning - while providing guide support that enables efficient, high-quality study delivery throughout the study life cycle.

• Accountable for achieving the final clinical deliverable within the time period specified in the contract with the customer. • Leads the local study team including cross-functional experts and vendor staff for study preparation and delivery. • Ensures development and maintenance of the country study plan and that critical study timelines are accurately forecasted and achieved. • Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities. • Manages the development of key study documents, plans & manuals according to local requirements.