Senior Director, Biostatistics Oncology
Ipsen Group
- # Sr. Director, BiostatisticsApplylocations: Cambridge (US): Paris: Londontime type: Full timeposted on: Posted Todayjob requisition id: R-21780**Title:**Sr. Director, Biostatistics**Company:**Ipsen Biopharmaceuticals Inc.**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at ** follow our latest news on **LinkedIn** and **Instagram**.**Job Description:****Job Title:**Senior Director, Biostatistics**Territory/TA Area:**Oncology**Division / Function:**R&D / Clinical / Biostats & Programming**WHAT -** **Summary & Purpose of the Position**The Senior Director, Biostatistics will be working in a cross functional team, responsible for providing program and project-level statistical expertise and leadership in the development of Ipsen oncology assets. This position reports to the Head of Biostatistics, based in the USA.The Senior Director will lead and mentor a team of biostatisticians, fostering a collaborative and innovative environment. This role is pivotal in advancing Ipsen's mission to improve patient outcomes through innovative treatments. The Senior Director will also engage with external stakeholders, including regulatory agencies and academic institutions, to ensure alignment with industry standards and scientific advancements. Ensuring data integrity and compliance with regulatory standards is a critical aspect of this role.The Senior Director will participate in the evaluation of prospective assets as part of the due diligence process, including initial assessments, pre-diligence, and full/confirmatory diligence. He/she will collaborate with other R&D functions in development of clinical development plans to inform the modelling of potential costs and revenue.The Senior Director is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data, and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, conduct, and evaluation of clinical trials. In addition, she/he will have the capacity to understand relevant multi-disciplinary knowledge and interact effectively with within the biometrics department with clinicians, regulatory affairs, medical writing, clinical operations, service/technology providers, as well data management and statistical programming.**WHAT -** **Main Responsibilities & Technical Competencies*** Work as program-level lead biostatistician in cross-functional team(s). Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.* Provide strategic leadership and direction within oncology programs, leveraging deep expertise to influence product and/or business strategy.* Lead and coordinate the planning and execution of biostatistics deliverables, ensuring quality and adherence to timeline, by collaborating with internal and CRO team members. .* Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes.* Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, and statistical analysis interpretation, reporting, and presentation of clinical study results.* Evaluate and interpret clinical trial data, prepare slides, and present results to internal and external stakeholders.* Provide oversight and guidance to ensure CRO partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Validate and QC CRO’s work to ensure the quality and accuracy of the statistical deliverables.* Support the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.* Play a critical role in shaping team development through ongoing training, mentorship and career development opportunities, and contribute to departmental strategy.* Lead or contribute to high-visibility, cross-functional initiatives of strategic importance, including long term digital and data strategy, refinement of external sourcing, and optimization of internal processes.**HOW - Behavioural Competencies Required****Ensures Accountability**• Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects) • Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear • Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus • Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others • Follows through on commitment and makes sure others do the sameThis role requires strong ownership of statistical deliverables, regulatory submissions, and oversight of CROs. Accountability is essential for ensuring data integrity and compliance.**Develops/Coaches Talent**• Able to identify and align career goals, and blend organizational objectives into a cohesive development plan for self and team • Able to coach • Provides structured, actionable, regular and directional feedback and acts as a coach to empower people to own their own growth/development • Prepares their own succession plans • Displays a radically human-centered mindset; puts people first; focuses on doing good • Demonstrates ability to build team effectivenessThe role includes leading and mentoring a team of biostatisticians. Coaching and talent development are critical to building a high-performing team.**Drive Vision and Strategy**• Paints a compelling picture of the vision (future status quo) and strategy that motivates others to actionThis role requires strategic leadership in oncology programs and influencing product strategy. Visionary thinking is essential for long-term success.**Manage Complexity**• Identifies contradictory information/demands/inputs to effectively solve problems • Develops and evaluates alternative scenario and solutions • Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impactThe role involves navigating complex data, regulatory requirements, and cross-functional collaboration. Managing complexity is key to effective decision-making.**Communicates Effectively**• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view • Communicates transparently, "tells it how it is" while keeping the communication respectful • Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes • Demonstrates gravitasEffective communication is vital for regulatory interactions, cross-functional leadership, and scientific publications.**HOW - Knowledge & Experience**Knowledge & Experience (essential):* 10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS; at least 5 years in a leadership role.* Advanced knowledge and practical experience of widely used clinical study designs as well as complex study designs.* Hands-on familiarity with common and advanced statistical methodology including methods adopted in adaptive design.* Expertise in applying, analyzing, reporting, and interpreting both descriptive and inferential statistics.* Strong knowledge of SAS programming concepts and techniques in the pharmaceutical, with the ability to proactively address strategic limitations; proficiency in tools such as SAS, R, EAST, nQuery, and JMP.* Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.* Excellent communication skills, both written and verbal, with the ability to convey complex statistical concepts clearly across functional areas.* Strong attention to detail.* Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams; strong interpersonal and relationship-building skills.* Demonstrated initiative, flexibility, and independent problem-solving skills with a proactive, positive approach.* Strong project and time management skills.* Deep understanding of statistical methodologies, clinical study designs, and the drug development process.* Ability to see the big picture while maintaining attention to detail.* Ability to manage multiple complex projects and assess resource needs.Knowledge & Experience (preferred):* Oncology drug development experience is highly desired.* Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.Education / Certifications (essential):* MS in statistics or biostatistics is required.Education / Certifications (preferred):* PhD in statistics or biostatistics is strongly preferred.Language(s) (essential):* Fluent in English, with excellent verbal and writtenWe are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
- J-18808-Ljbffr Ipsen Group
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Director, Biostatistics Oncology in Cambridge, MA vacancy
$235k - $295k
...to develop therapies for diseases beyond oncology. Bicycle Therapeutics is... ...goals and strategic priorities for the biostatistics function, ensuring its work is directly... ...clinical development plan. Collaborate with senior leaders in Medical, Clinical Research, and...SeniorFull timeWork at officeImmediate startRemote workWork from homeFlexible hours3 days per weekBicycle Therapeutics Limited
Lexington, MA11 hours ago- Title Senior Director, Biostatistics Company Ipsen Biopharmaceuticals Inc. A global biopharmaceutical company focused on oncology, rare disease, and neuroscience. Summary The Senior Director, Biostatistics works in a cross‑functional team, providing program and project‑...Senior
- ...Senior Director Of Biostatistics As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership...Senior
Cedent Life Talent
Boston, MA17 hours ago - ...Senior Director, Biostatistics Regeneron is seeking a Senior Director, Biostatistics to drive our Immunology and Inflammation therapeutic area. In this role, a typical day might include: The incumbent will have responsibility for strategic and operational activities...Senior
Regeneron
Cambridge, MA1 day ago $311k - $388.5k
...patients faster and more efficiently. About the Position Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading...SeniorWork at officeLocal areaRelocation3 days per weekFormation Bio
Boston, MA2 days ago$242k - $313k
...patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Senior Director, Biostatistics is a senior scientific and functional leader responsible for providing strategic statistical leadership for the organization...SeniorLocal areaFlexible hours2 days per weekBeeline Medicines
Boston, MA4 days ago$210.9k - $379.2k
...worldwide. Moderna is seeking a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through commercialization... ...team leadership, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs...SeniorPermanent employmentWork at officeWork from homeWorldwideJobleads-US
Cambridge, MA2 days ago$230.72k - $345k
...Job Summary The Senior Director, Biostatistics, provides leadership, oversight, and technical/scientific direction across multiple therapeutic areas. This role leads and develops a high-performing biostatistics team that delivers both strong scientific engagement and...SeniorTemporary workLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Boston, MA4 days ago- Alnylam Pharmaceuticals, Inc. is seeking a Senior Director in Biostatistics to lead the development of advanced statistical methodologies for clinical trials. This hybrid role emphasizes innovative trial design and offers the opportunity to shape statistical strategies...Senior
$191.2k - $286.8k
...Director, Biostatistics Boston, MA Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering... ...cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss...Tango Therapeutics
Boston, MA3 days ago$246.5k - $333.5k
Senior Director BiostatisticsHead of Statistical Innovation & MethodologyOverviewAt Alnylam, the Senior Director Biostatistics, Head of Statistical Innovation & Methodology will provide scientific leadership in advanced statistical methodology, innovative trial design...SeniorFull timeTemporary workLocal areaRemote workFlexible hours- Monte Rosa Therapeutics, Inc in Boston is seeking a Director of Biostatistics responsible for leading the design and analysis of clinical trials focused on inflammation and oncology. The ideal candidate will have a PhD and over 15 years of experience in clinical drug development...
$263k - $321k
...our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime... ...Summary Prime Medicine is seeking an experienced Senior Director, Biometrics to serve as the senior biostatistics leader for the organization while providing strategic...SeniorFull timeTemporary workInterim role$227.4k - $284.26k
...Senior Director, Biostatistics Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines...SeniorFlexible hoursZenas BioPharma
Waltham, MA4 days ago- BioSpace is looking for a Senior Director, Head of Oncology Alliance Management in Boston, MA. The role focuses on shaping the global alliance management strategy for Oncology, leading a high-performing team to maximize the value of critical partnerships in drug discovery...Senior
- Merck & Co. is seeking an Associate Director Field Reimbursement to join their oncology team in Boston, Massachusetts. This role serves as a field-based specialist, providing necessary reimbursement support to healthcare professionals to enhance patient access to oncology...Senior
- Ipsen Biopharmaceuticals Inc. is seeking a Senior Director, Biostatistics to provide leadership in the development of oncology assets within a cross-functional team. The role involves strategic support for asset teams, ensuring data integrity, and guiding a team of biostatisticians...Senior
- Ipsen Group is seeking a Sr. Director, Biostatistics to lead statistical strategy and team in oncology projects. The ideal candidate will have over 10 years of pharmaceutical experience, including 5 years in leadership roles. Responsibilities include mentoring biostatisticians...Senior
- IPSEN is seeking a Senior Director of Biostatistics in Cambridge, MA, responsible for providing statistical expertise in oncology projects. The role involves leading a team and engaging with stakeholders to ensure scientific alignment and data integrity. The ideal candidate...Senior
$150k - $225k
...breakthrough drugs to improve outcomes for patients through the creation of Gemini Digital Twins of human disease with a focus on oncology and neurodegenerative diseases. Aitia collaborates with pharmaceutical companies, academic medical centers, data partners, and patient...SeniorContract workWork at officeLocal area$220.47k - $330.7k
...diverse minds to make a real difference, there’s only one choice. Senior Director, Licensing Officer The Senior Director, Licensing Officer (LO) reports to the Head of Business Development & Licensing, Oncology & Radiology. You will identify, shape, negotiate and execute...SeniorLocal areaBayer AG
Cambridge, MA1 day ago- ...Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. Position Summary We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical Officer. In this position you will be acting as the statistical lead for one program or...SeniorInterim roleRemote workFlexible hours
Atavistik Bio
Cambridge, MA8 days ago $200.8k - $301.2k
...to make this a reality by bringing together our world-leading oncology pipeline with emerging innovations and technologies. We are... ...external innovation and building strong scientific networks. The Senior Director, Transactions, sits within the Oncology R&D Strategy...SeniorFull timeTemporary workWork at officeFlexible hours3 days per week$100k - $180k
You will join a growing oncology-focused Data Sciences function and provide statistical... ...studies within our expanding portfolio. The Senior Biostatistician contributes to the... ...in Cambridge, UK and reports to Head of Biostatistics. What you can expect from us At Orion...SeniorFull timeImmediate start$176.1k - $287.3k
...statistician/biostatistician to support Clinical Biostatistics with Global Development. In this... ..., and publications. As an Associate Director, the incumbent will be responsible for... ...Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar...Full timeLocal area$221k - $249k
...encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various internal and external stakeholders (e.g. Clinical Development, Regulatory,...Local areaRemote workAmylyx Pharmaceuticals Inc
Cambridge, MA17 hours ago$230k - $250k
...and where our shared mission unites us across functions and geographies. Location: Boston, MA preferred The Director, Biostatistics serves as a senior individual contributor to statistical leadership at Vor Biosciences, providing strategic and operational...Interim roleWorldwideFlexible hoursVor Bio Co-ops
Boston, MA5 days ago- ...Director Of Biostatistics Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology... ...event analysis and methodology Experience working in oncology and/or cardiology clinical trials and/or experience with...Work experience placementRemote work
Tempus
Boston, MA2 days ago $183k - $275k
...Director, Biostatistics 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...Contract workTemporary workRemote workWork from homeFlexible hours3 days per weekAgios Pharmaceuticals
Cambridge, MA1 day ago$212.5k - $287.5k
...Director, Biostatistics The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical...Full timeTemporary workLocal areaWorldwideFlexible hoursAlnylam
Cambridge, MA17 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Biostatistics Oncology. Be the first to apply!
Related searches
- director of automation Cambridge, MA
- director lease administration Cambridge, MA
- director work from home Cambridge, MA
- director of process improvement Cambridge, MA
- director of culinary Cambridge, MA
- tennis director Cambridge, MA
- senior director Cambridge, MA
- director of administration Cambridge, MA
- nonprofit director Cambridge, MA
- director workforce management Cambridge, MA