Biogen

• Collaborate with US Medical Directors, US brand team, clinical partners, and cross‑functional stakeholders to develop and implement regional field medical strategies • Lead team of MSLs to drive education resulting in Measurable HCP Behavior Change and improved Patient Outcomes • Establish and monitor KPIs that measure MSL impact and execution against medical and brand strategy • Maintain a deep understanding of the therapeutic area, products, competitive landscape, and evolving regulatory and treatment guidelines • Lead a clear and consistent operating rhythm, including weekly review of field metrics and KPI dashboards, to inform performance management and data‑driven coaching • Ensure MSLs have complete clarity on medical strategy, aligned engagement plans, and consistent execution against defined KPIs • Gather high‑quality, strategically aligned Voice of KOL (VoKOL) insights compliantly • Oversee effective use of field tools and systems to ensure alignment with medical strategy • Serve as the primary regional field medical liaison, enabling strong collaboration across Medical, MDO, and cross‑functional partners

Title: Sr. Principal Biostatistician Location: Remote, USA Job Description: Full time job requisition id REQ22951 About This Role: As a Senior Principal Biostatistician, you will be at the forefront of leading study design and data analysis, providing statistical expertise for our products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You'll play a key role in reviewing study setup activities, ensuring the integrity of randomization and CRFs, and leading biostatistical efforts for assigned projects. Your work involves performing statistical analyses, interpreting results, and preparing comprehensive clinical study reports. Additionally, you'll assist in preparing responses to statistical issues in regulatory or legal settings and liaise with clinical research personnel to align statistical support with our development strategy. Your contributions to process improvement initiatives and mentorship will aid in the long-term growth of our department. What You’ll Do: · Lead biostatistics representation on project or study teams and provide statistical expertise. · Define statistical methodologies, analyze data, and report results for clinical development plans. · Train and supervise contract statisticians, ensuring quality deliverables. · Assist in addressing statistical issues in regulatory, legal, or other challenges. · Serve as a peer reviewer and internal consultant on broad statistical issues. · Participate in process improvement initiatives and mentor new/junior biostatisticians. · Conduct modeling and simulations as needed. · Collaborate closely with study or project teams for data interpretation and reporting. · Work with statistical programmers, data management, and vendors to deliver analysis results. · Collaborate with medical writers to complete study reports and manuscripts. · Supervise FSP statisticians in assigned tasks. Who You Are: You are a detail-oriented individual with a strong analytical mindset, capable of managing multiple projects simultaneously. Your ability to effectively communicate complex statistical concepts in lay terms sets you apart, alongside your leadership skills and ability to work collaboratively with diverse teams. Your proactive approach to problem-solving and your dedication to continuous learning in statistical methodologies make you an invaluable asset. Required Skills: · Degree in Biostatistics (Ph.D Preferred) or equivalent with a minimum of 3+ years relevant work experience in the pharmaceutical/biotech industry. · Thorough understanding of statistical principles and clinical trial methodology. · Ability to provide technical solutions to a wide range of difficult problems. · Conversant with R, SAS, or other statistical software programming languages. · Working knowledge of regulatory guidelines related to statistical analysis. · Strong ability to manage multiple projects and conflicting priorities. · Excellent written and verbal communication skills. Preferred Skills: · Experience with statistical components of regulatory submissions. · Detailed knowledge of R or SAS procedures and computing tools for modeling and simulations. · Proven experience in mentoring junior staff and contributing to process improvements. Although we are open to Remote candidates, the strong preference would be to have a Hybrid presence to a Biogen office (Cambridge, MA or RTP, North Carolina). Job Level: Management Additional Information The base compensation range for this role is: $134,000.00-$179,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: - Medical, Dental, Vision, & Life insurances - Fitness & Wellness programs including a fitness reimbursement - Short- and Long-Term Disability insurance - A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) - Up to 12 company paid holidays + 3 paid days off for Personal Significance - 80 hours of sick time per calendar year - Paid Maternity and Parental Leave benefit - 401(k) program participation with company matched contributions - Employee stock purchase plan - Tuition reimbursement of up to $10,000 per calendar year - Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

• Manage up to 20 FSP staff assigned across the portfolio to deliver the CTDU’s program and study-level operational objectives. • Lead resource forecasting and assignment to meet key business drivers and maximize FSP performance within annual operating plan. • Develop and revise role-specific SOPs to drive consistency and quality across FSP staff. • Design and implement training programs in collaboration with FSP vendors and CTDU stakeholders • Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions and policy compliance. • Represent CTDU in FSP vendor governance and oversight activities. • Monitor and report applicable FSP role performance metrics. • Partner with CTDU stakeholders to align on goals and promote continuous improvement.

• Accountable for providing Data Management expertise to assigned studies and/or programs by overseeing data quality and Data Management performance. • Ensures consistent implementation of data collection standards, data cleaning standards, and quality plans. • Contribute to the strategic development of the Data Management department, including processes, technology, data standards, reporting, process improvement, and innovation, and support the implementation of related process and system enhancements. • Responsible for the hiring, assignment, and development of staff within direct or indirect reporting lines. • Provide effective coaching and mentoring to ensure consistently high levels of performance and productivity. • Deliver ongoing feedback, coaching, and career development support, including engagement and retention activities, to maximize staff potential. • Act as a point of escalation for Data Management activities by interfacing with cross-functional customers. • Resolve complex issues through effective problem solving and appropriate escalation to senior management. • Research and resolve complex issues by leveraging appropriate resources and ensuring clear, thorough communication to support departmental awareness.

Role Description The Associate Medical Director, Transplant, is part of the Global Medical Affairs (GMA) Transplant team, a strategic partner within Biogen, that provides medical and scientific expertise across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Associate Medical Director will collaborate closely with other members of the GMA Transplant team to coordinate and execute key medical strategies and tactics in support of the global launch of felzartamab in transplant indications. What You Will Do - Serve as a key medical scientific expert contributing to the development and review of educational content across transplant indications and ensuring consistency of therapeutic area messaging and adherence to established standards. - Collaborate with cross-functional partners (Clinical Development, Value & Access, Commercialization, and Affiliate Medical Affairs) as a subject matter expert to support the implementation and execution of strategic medical initiatives, which may include protocol review, scientific resource development, evidence generation, and internal training materials. - Collaborate with GMA transplant team members on the development and execution of medical advisory boards. - Partner with the GMA transplant team to support development of the annual medical strategic plan aligned with Medical Affairs leadership objectives. - Lead or support the execution of evidence generation activities. - Attend major scientific congresses and conferences to gather clinical insights, assess emerging data, and support the development of conference coverage materials and internal training. - Coordinate and implement initiatives for the GMA transplant team in collaboration with cross-functional stakeholders. Qualifications - PharmD, PhD, MD, DNP or other advanced degree in the life sciences. - Minimum five years' experience in the pharmaceutical industry, ideally within Medical Affairs; combination of relevant clinical/research experience with pharmaceutical experience may be considered. - Solid organ transplant therapeutic area expertise. - Excellent communication (written and oral), including presentation skills. - Demonstrates strong interpersonal skills and the ability to effectively operate and exert influence within a highly matrixed organization. - Solid project management skills to include the ability to take initiative to solve complex and challenging problems. Benefits - Medical, Dental, Vision, & Life insurances. - Fitness & Wellness programs including a fitness reimbursement. - Short- and Long-Term Disability insurance. - A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31). - Up to 12 company paid holidays + 3 paid days off for Personal Significance. - 80 hours of sick time per calendar year. - Paid Maternity and Parental Leave benefit. - 401(k) program participation with company matched contributions. - Employee stock purchase plan. - Tuition reimbursement of up to $10,000 per calendar year. - Employee Resource Groups participation. Company Description Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Role Description In this strategically focused role of Clinical Country Site Lead, you will drive global clinical development strategies by providing essential local operational and scientific expertise. Your contributions will be pivotal in enhancing global customer satisfaction and supporting the delivery and execution of Biogen's development pipeline. - Maintain up-to-date local knowledge of therapeutic areas researched by Biogen, standards of care, and clinical trial requirements. - Engage in operational and scientific discussions as the local QSDO representative to offer country-level insights on therapeutic areas related to studies and programs. - Support and drive global operational strategy by providing study information. - Highlight country-level capabilities and needs through investigator and site knowledge. - Manage relationships with investigators and sites to foster collaboration and satisfaction. - Position Biogen as the preferred partner for clinical trials through strong investigator partnerships. - Lead local activities in the country and site selection process, ensuring stakeholder input. - Act as the primary country-level contact for strategic development and execution of sponsor oversight of CRO activities. - Oversee compliance with ICH/GCP, local regulations, and sponsor requirements through Sponsor Oversight Visits and audit support. - Serve as the primary contact for all QSDO clinical studies, ensuring issue resolution and timely information flow. - Monitor and analyze trial and country progress to support QSDO deliverables and country goals. - Address local trial challenges and ensure effective communication and alignment with global teams. - Act as Lead CCSL for study or program leadership as required, coordinating various activities. - Train aCCSLs/CCSLs on therapeutic areas, program communications, and CSO activities. - Perform company business in compliance with regulations, policies, and procedures. Qualifications - University degree with a science background or equivalent education and experience; advanced degree preferred. - Minimum 8 years of clinical research experience, with an emphasis on managing clinical trial activities and sponsor oversight. - Strong communication skills, including proficiency in English in non-English speaking countries. - Understanding of the cross-functional drug development process and scientific knowledge across key therapeutic areas. - Knowledge of ICH/GCP, country regulations, and clinical trial monitoring in an outsourced model. - Strong organizational and project management skills. - Effective working knowledge of IT tools for virtual teamwork. - Excellent knowledge of clinical operational activities across local geography. - Ability to handle high volumes of tasks with varying complexity and priorities. - Proficiency in working across multiple digital platforms and early adoption of new systems/applications. Preferred Skills - Experience in managing sponsor oversight activities in an outsourced/FSP model with CROs/vendors. - Proven ability to build relationships throughout and across the organization while operating remotely. - Willingness to travel 20% - 25%. Benefits - Expected salary range: $127,000 to $169,750, including eligibility for a discretionary bonus. - Base salary determined through an analytical approach utilizing relevant skills & experience, job location, and internal equity. - Regular employees are eligible for both short-term and long-term incentives, including cash bonuses and equity incentive opportunities. - Full and highly competitive range of benefits designed to support employees’ and their families' physical, financial, emotional, and social well-being. - Includes health care, retirement, paid time off, and ancillary programs such as a fully paid sabbatical after six years of service. - Employee Stock Purchase Plan participation, education assistance, and more. Company Description We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. - Our team encompasses some of the most talented and passionate achievers. - Unparalleled opportunities for learning, growth, and expanding skills. - We work together to deliver life-changing medicines, with every role playing a vital part in our mission. - Committed to building on our culture of inclusion and belonging.

• Support the design and execution of clinical trial protocols with a focus on feasibility, quality, and patient safety • Manage day-to-day study operations and ensure compliance with GCP and regulatory standards • Track study timelines, milestones, budgets, and proactively mitigate risks • Collaborate with Study Management Teams to guide decision-making using data insights • Oversee CROs and vendors to ensure high-quality execution of outsourced activities • Maintain study documentation and ensure data integrity across systems • Drive continuous improvement and promote best practices across clinical operations

Role Description The Regional Medical Account Director (MAD) role is a part of the Medical Market Access Team in US Medical, a strategic partner within Biogen, that helps inform medical access and care across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Regional MAD combines scientific expertise with knowledge of US managed care organizations, health care policy as well as health economics and outcomes research (HEOR) to serve as the medically accountable lead for Regional Payor/Health System Accounts. - Lead scientific engagement & support HEOR Medical strategy and business objectives with assigned US healthcare systems and Regional payer related organizations. - Work closely with cross-functional stakeholders to enhance overall department asset strategies and goals. - Anticipate, identify, and address population level scientific, outcomes research, and health policy needs. - Serve as the Medical lead for assigned Regional Accounts to drive strategy development and account engagement. - Engage in proactive and reactive scientific exchange to disseminate scientific and health economics/outcome information. - Build strong relationships to help Biogen understand customer needs and facilitate approaches to real-world evidence (RWE). - Collaborate with cross-functional colleagues to elevate Biogen’s ability to meet customer needs. - Be highly accountable to qualitative and quantitative medical excellence performance goals. - Deliver against engagement plans for key decision makers by managing and deploying resources. - Capture and report medical insights to inform medical and clinical strategies. Qualifications - Minimum 5 years of experience in a Managed Care/PBM, VA/DoD, CMS, State Medicaid, health care consulting, pharmaceutical industry or related environment with a managed market/outcome focus. - Experience in a field based Medical Affairs or Market Access role working with payers. - Advanced scientific or clinical degree (preferred Pharm.D., Ph.D., MD, DNP). - Excellent communication and formal presentation skills. - Organizational skills and ability to effectively manage several projects simultaneously. - Able to work independently in field location (with 60% travel). - Must be 18 years of age or older with valid Driver’s License and an acceptable driving record. Requirements - Account management experience in a commercial or clinical setting is preferred. - Completion of relevant clinical residency, fellowship or work experience may be considered. - Demonstrated ability to effectively lead and collaborate with cross-functional colleagues. - Clinical experience and subject matter expertise in neurology and/or immunology is optimal. Benefits - Medical, Dental, Vision, & Life insurances. - Fitness & Wellness programs including a fitness reimbursement. - Short- and Long-Term Disability insurance. - A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31). - Up to 12 company paid holidays + 3 paid days off for Personal Significance. - 80 hours of sick time per calendar year. - Paid Maternity and Parental Leave benefit. - 401(k) program participation with company matched contributions. - Employee stock purchase plan. - Tuition reimbursement of up to $10,000 per calendar year. - Employee Resource Groups participation.

Role Description The purpose of this position is to be the patient facing expert on the Rare Disease patient journey and the liaison for all Biogen team members involved in the process. The Family Access Manager (FAM) is responsible for engaging cross functional stakeholders on the next steps to support appropriate patients getting started and staying on rare disease therapies. The FAM will get to the root of any logistical and/or non-clinical issues impacting treatment initiation and ongoing therapy. - Identify the point person, tools, or resources to resolve issues (Account Executive, Market Access & Reimbursement, and/or Case Management). - Provide appropriate patient education and support site of care contacts as they navigate non-clinical barriers. - Educate on reimbursement, disease state, product education, advocacy, and support for individuals living with rare diseases and their loved ones/caregivers. - Interact with physicians, nurses, pharmacists, ancillary staff, patients/families/caregivers, and advocacy partners to prevent and address barriers to patient access. - Serve as the primary source for all local/regional patient advocacy activities. What You will Do - Support patients/families to work through the steps required to gain access to therapy (disease and product education, site of care coordination, understanding of payer policy and procedure, and other support services). - Play the role of patient advocate in cross functional meetings with internal partners (Case Manager, Account Executive, Market Access & Reimbursement) to build and maintain accurate case plans for patients. - Work cross functionally to identify and support the resolution of patient access barriers including insurance coverage, reimbursement, financial limitations, site of care, and procurement/distribution issues. - Collaborate with Market Access & Reimbursement team members to ensure appropriate reimbursement and engage with payers, specialty pharmacies, and specialty distributors to ensure access. - Provide strong emotional support for individuals living with rare diseases and their loved ones/caregivers. - Be knowledgeable of changes in the patient access environment to proactively identify issues that may impact access. - Complete a comprehensive assessment of the individual needs of the patient considering the patient’s family and team of healthcare providers. - Develop and offer solutions to the family, including communication of alternative insurance options. - Educate patients, families, and caregivers on product and all Biogen Patient services. - Develop activities with the goal of achieving greater openness and understanding of rare disease. - Build your own rare disease network/relationships through local advocacy groups, rare disease related events, and attending national conferences. - Become an expert on the Rare Disease portfolio and Biogen resources to provide the highest level of patient/caregiver support. Qualifications - 5+ years’ business experience in the healthcare or biotech industry with at least 3 years field-based experience in account management, sales, and/or field reimbursement. Rare disease experience is preferred. - A successful record in field reimbursement, clinical education or in pharmaceutical sales/management of products that required significant payer and reimbursement involvement. - Experience with physician-administered drugs (PADs)/biologics and various outpatient sites of service. - Seasoned, mature pharmaceutical professional with a comprehensive understanding of field/patient reimbursement, charitable funding, non-profit organizations. - Experience leading cross-functionally and influencing without authority. - Case management or experience supporting patients/caregivers directly is a plus. - Familiarity with the relevant legal and regulatory environment in the biotech industry. - Strong EQ, communication, listening skills, and empathy skills required - Bilingual is a plus. - Effective at managing complex individualized cases. - Must be comfortable spending 60% of their time traveling. - Driving is an essential duty of the job; candidates must have a valid driver’s license and an acceptable driving record according to Biogen policy. Education - BS Required; master’s degree a plus. Job Level - Management Additional Information - The base compensation range for this role is: $155,000.00-$208,000.00. - Base salary offered is determined through an analytical approach utilizing a combination of factors including relevant skills & experience, job location, and internal equity. - Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities. - In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families' physical, financial, emotional, and social well-being. - Benefits include Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Short- and Long-Term Disability insurance, paid vacation, paid holidays, sick time, Paid Maternity and Parental Leave, 401(k) program participation, Employee stock purchase plan, and Tuition reimbursement.

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight • Provides statistical programming expertise within Biogen, including demonstrated proficiency in CDISC SDTM (Study Data Tabulation Model) and CDISC ADaM (Analysis Dataset model) implementation • Authors analysis data set specifications including the identification of potential data issues or areas of critical data examination • Engages with Biostatistics to define and document programming endpoint algorithms • Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components (input to reviewer’s guides, annotated CRF, define and XPTs); works with SMEs in SSM to ensure compliance to eSUB standards • Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT • Serves as the Statistical Programming Lead to achieve milestones for an indication of a drug program/Therapeutic Area; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs • Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan • Aligns internal and external project team members on statistical programming requirements, deliverable status, and resource needs