Director, Biosimilars Evidence Generation
Vor 5 Tagen
**Job Description**:
The Biogen Biosimilars Unit (BBU) is committed to commercialization in several biologic categories and product launches. We are a team committed to advancing care for patients needing life changing therapies. As recent industry reports suggest, Biosimilar products in global healthcare have an opportunity to exceed billions of savings during the next five years - Biogen is committed to be at the forefront of this opportunity for patients and the healthcare system.
In this amazing opportunity the incumbent will be accountable for all biostatistics, statistical programming and clinical data management activities and deliverables for a portfolio of Biosimilars in both pre/ post-approval setting.
You will act as a highly visible member of the Biosimilars R&D leadership team and like this represent Evidence Generation in meetings with Executive Committee, Regulatory Bodies or external development partners.You will provide significant input to Clinical Development planning / strategies as well as to regulatory submission aspects.
The position will require you to build strong connections to stakeholders across the company and to position yourself as a trusted and honored leader driving initiatives while aligning with all parties involved. Finally, you will be responsible for managing, developing and growing a team of high performing biostatisticians, statistical programmers and clinical data managers.
**Your Responsibilities**:
- Lead a team of statisticians, statistical programmers and clinical data managers (5-7 FTEs) within Biosimilars Evidence Generation
- Providing guidance and support for all biostatisticians, statistical programmers and clinical data managers in assigned projects. Development of staff through coaching and training, retaining talents and managing performance
- Providing broader mentoring and guidance to ensure that the Biosimilars Evidence Generation missions and goals are achieved
- Directing overall statistical activities for projects assigned including implementation of efficient, consistent, and practical processes for Biostatistics and monitoring of efficient resource allocation and usage for assigned projects
- Providing guidance and direct input into strategy, planning and contents of clinical development plans as well as key components of regulatory submissions
- Striving to increase the scientific agility by facilitating the implementation of innovative approaches and increasing operational efficiency
- Serving as the primary functional reviewer/ approver of e.g. CRFs, protocols, analysis plans and clinical study reports
- Providing guidance and direct input in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and representing Biostatistics in key regulatory meetings or meetings with KOLs
- Be accountable for overall quality and accuracy of the deliverables of the Evidence Generation team
- Be accountable for oversight of activities performed by CROs/ external partners
- Oversee the implementation of the data standards and exchange formats across all Contract Research Organizations (CROs) to ensure consistency in collection and reporting of clinical data that they are in an appropriate regulatory required format following CDISC
- Participate in and/or leading of cross-functional initiatives representing Evidence Generation as well as participating in key Biosimilars R&D governance meetings
- Establish and maintain good working relationship within Biosimilars R&D and Innovator R&D teams
- Represent Biogen in statistical forums at conferences or scientific meetings
**Who you are**
You are an experienced Biostatistician used to be an active and constructive member of R&D leadership groups. You know well how to balance, challenge and unite different opinions to come up with strong and innovative solutions. You strive to always challenge the status quo in order to deliver excellent and outstanding results to solve complex problems.
**Qualifications**:
**Your education & experience**
- PhD in Biostatistics/Statistics or equivalent with a minimum of 9-10 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 11-12 years relevant experience
- Substantial past regulatory experiences, including interactions with FDA, EMA, and PMDA and BLA/NDA/MAA submission experiences
- Strong knowledge of relevant guidelines for regulatory activities (e.g. ICH E3, ICH E8, ICH E9 (R1), ICH E10)
- Broad and thorough understanding of statistical principles and clinical trial methodology (e.g. estimands, missing data, blinded sample size-reassessment, non-randomized trials, bio-equivalance trials)
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Extensive knowledge in the development of clinical development plans (CDPs) including Biomarker, PK, PK/ PD and efficacy/ safety studies
- Strong knowledge of programming in SAS and/ or R
- Excellent know
-
Evidence Generation Associate
Vor 7 Tagen
Baar, Schweiz AstraZeneca Vollzeit**Position: Evidence Generation Ass**ociate** **Location: Baar, Switzerland** **Competitive salary & benefits** The Medical Affairs team is looking for an Evidence Generation Assistant (M/F) to join our office in Switzerland. Being part of our team offers you the opportunity to work in a fast-paced, constantly evolving environment with clinical trials in...
-
Regional Director Medical Evidence
Vor 3 Tagen
Baar, Schweiz AstraZeneca Vollzeit**Medical Evidence Director EuCan** **Zug, Switzerland** Be part of changing the practice of medicine forever. A place to be at the forefront; proactive, innovative and brave, we don’t stop. It means we dare to do the big studies in the real world, utilising primary and secondary data, leading the field in evidence generation and external scientific...
-
Baar, Schweiz Biogen VollzeitCompany Description **Job Description**: **Overview** A randomized controlled trial (RCTs) allows estimation of the treatment effect of an intervention compared to a control in the study population, unconfounded by treatment assignment. Intercurrent events are defined in the ICH E9 (R1) guideline as events that occur after treatment initiation and...
-
Evidence Generation Manager
Vor 7 Tagen
Baar, Schweiz AstraZeneca VollzeitEvidence Generation ManagerLocation: Baar, Switzerland (hybrid)What you’ll do...This role involves leading the design and analysis of Real-World Data (RWD) projects, ensuring that data-driven insights are central to decision-making processes. Responsibilities include driving coordinated Evidence Generation plans and implementing studies that support both...
-
Medical Evidence Quality Director
Vor 4 Tagen
Baar, Schweiz AstraZeneca Vollzeit**Title - Medical Evidence Quality Director** (International)** **Location - Luton UK or Zug Switzerland.** **Salary - Competitive with attractive package** We are now recruiting an** Medical Evidence Quality Directo**r within **BioPharmaceuticals Medical (BPM).** Medical Affairs ensures the best patient outcomes by providing healthcare decision-makers...
-
Global Head of Biostatistics
Vor 7 Tagen
Baar, Schweiz Proclinical VollzeitProclinical are recruiting a Global Head of Biostatistics for a pharmaceutical organisation. This role is on a permanent basis and is located in Baar. **Responsibilities**: - Responsible for oversight of actions conducted by CROs/external partners. - Guide a team of biostatisticians, statistical programmers and clinical data managers in biosimilars...
-
Associate Director, Biostatistics
Vor 7 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description**: - The Associate Director of Biostatistics is responsible for providing the statistical expertise, strategy and managing the activities for one or more clinical development programs (CDPs), either at an early or late development phase, to ensure valid and efficient study designs that allow clearly interpretable results, and timely...
-
International Epidemiology Associate Medical
vor 1 Woche
Baar, Schweiz AstraZeneca Vollzeit**ABOUT ASTRAZENECA** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...
-
Innovation & Business Excellence (Ibex) Director
Vor 3 Tagen
Baar, Schweiz AstraZeneca Vollzeit**Job title: Innovation & Business Excellence (IBEX) Director, Switzerland** **Location: Baar, Switzerland** We are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear - shaping the future by spotting a scientifically-led commercial opportunity and acting now to operationalise...
-
Associate Director, Global Brand Lead Immunology
Vor 7 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description**: **Job Overview**: Reporting to the Global BBU Immunology Marketing Lead, and working within a matrix environment, this individual must be adept at multi-tasking and possess an entrepreneurial spirit as they will lead several projects and closely collaborate on multiple biosimilars brands with key cross functional partners (Medical,...
-
Global Medical Director, Lupus
Vor 2 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description** Medical Director Global Medical Affairs, Lupus** Location: Baar, Switzerland ( working as per our local hybrid HR policy) **About This Role** As Global Medical Affairs Director, Lupus you will be a strategic partner providing expert medical leadership to guide development, launch planning, and support for Lupus pipeline products to...
-
Director Medical Affairs
vor 19 Stunden
Baar, Schweiz Medela LLC Vollzeitlocations- Baar- time type Full time- posted on Posted Today- job requisition id R875- Are you interested in working for a company that is passionate about its customers? That lives its values and nurtures its employees? Then Medela is the company for you._ - We are seeking a Global Director of Medical Affairs & Education (M/F /d) to join our team.- Your...
-
Baar, Schweiz Biogen Vollzeit**Job Description**: **About This Role** This role is a part of Worldwide Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve measurable and meaningful patient outcomes. As an agile, world-class organization, we are the translational bridge between science, the healthcare...
-
International Associate Medical Director, Lung
vor 19 Stunden
Baar, Schweiz AstraZeneca Vollzeit**ABOUT ASTRAZENECA** At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our...
-
Baar, Schweiz AstraZeneca Vollzeit**ABOUT ASTRAZENECA** Work in a dynamic environment where our markets are constantly evolving and adapting. It means we approach every day with an innovative and creative mindset - searching for unexpected things, with the backing to experiment and learn from failures. We’re instrumental in launching a huge variety of cutting-edge scientific products in...
-
Associate Director Value
Vor 2 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description** About This Role** You will as Associate Director Value & Access Rare Diseases support the development of market access plans and strategies in support of Biogen’s rare disease assets in EU & BIR affiliates (all ex-US markets). The role holder will be responsible for supporting health technology assessment and reimbursement submissions,...
-
Director Pricing and Tenders
Vor 2 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description**: This role is office based in Baar, Switzerland. **Background**: 90% or more of the Biosimilars (BBU) business is through Tenders & Contracts and this role is key in leading the day to day Pricing and T&C work across Europe Canada and Partner Markets (ECP) to drive tender win rates and strategically manage pricing for both existing and...
-
Baar, Schweiz Biogen Vollzeit**Job Description**: Neurological diseases are highly complex and devastating, and there are still significant challenges in how we understand and treat them. At Biogen Digital Health (BDH), we aspire to transform patients’ lives by making personalized & digital medicine in neuroscience a reality. Leveraging measurement science and digital technologies, we...
-
Medical Affairs Manager
Vor 5 Tagen
Baar, Schweiz AstraZeneca Vollzeit**Medical Affairs Manger - Breast Cancer** The Medical Affairs Manager (MAM) works as a medical affairs expert leads and supports all aspects of drugs in the field of oncology within cross-functional teams. The Medical Affairs Manager reports to the Therapeutic Area Lead Breast/Gyne Cancer. **Your main tasks** - You work as a strategic partner and as a...
-
Responsible Person
Vor 3 Tagen
Baar, Schweiz Medison group VollzeitMedison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy...