- Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) ("HARMONi")
- Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients ("HARMONi-3")
- Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology
- Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies
- Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses
- Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications
- Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
- Review vendor data transfer specifications and ADaM programming specifications
- Lead assessment and introduction of novel statistical methodologies to implement solutions
- Represent biostatistics function or biometrics department in cross function teams
- Work with department leader to develop and implement department policies, standards and procedures
- Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
- Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
- Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
- Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development
- Ph.D. in Statistics, Biostatistics or equivalent area with 15+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (18+ years) can be considered.
- 15+ years of scientific programming experience with SAS or R.
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required).
- Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred.
- Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used. Excellent written and verbal communication skills
- Good working knowledge of ICH, FDA and GCP regulations and guidelines
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
- Strong computer and database skills
- Attention to detail, accuracy and confidentiality
- Clear and concise oral and written communication skills
- Excellent organizational skills
- Critical thinking, problem solving, ability to work independently.
- Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
- Communicate effectively and articulate complex ideas in an easily understandable way
- Prioritize conflicting demands.
- Work in a fast-paced, demanding and collaborative environment
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Director, Biostatistics
2 weeks ago
Cargo Therapeutics, Inc. San Carlos, United StatesThe Director, Biostatistics will be responsible for partnering with scientists in Clinical, Safety, Translational Medicine, Regulatory, and Product Development on clinical development projects, development science applications, and/or process/product manufacturing applications, a ...
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Associate Director, Biostatistics
2 weeks ago
Arcellx, Inc. Redwood City, United StatesWho We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...
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Associate Director, Biostatistics, Oncology
2 weeks ago
Ascendis Pharma Palo Alto, United StatesHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, were advancing programs in Endocrinology Rare D ...
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Director, Biostatistics
2 weeks ago
Cargo Therapeutics San Carlos, United States· The Director, Biostatistics will be responsible for partnering with scientists in Clinical, Safety, Translational Medicine, Regulatory, and Product Development on clinical development projects, development science applications, and/or process/product manufacturing applications ...
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Associate Director Biostatistics
2 weeks ago
Meet Redwood City, United StatesOur client is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expe ...
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Associate Director, Biostatistics
1 week ago
Arcellx, Inc. Redwood City, United StatesWho We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...
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Associate Director Biostatistics
2 weeks ago
Meet Redwood City, United StatesOur client is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expe ...
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Associate Director, Biostatistics
1 week ago
Arcellx, Inc. Redwood City, United StatesWho We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...
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Associate Director, Biostatistics, Oncology
2 weeks ago
Ascendis Pharma Palo Alto, United StatesJob Description · Job DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing ...
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Associate Director Biostatistics
1 week ago
Meet Redwood City, United StatesOur client is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expe ...
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Associate Director, Biostatistics, Oncology
1 week ago
Ascendis Pharma Stanford, United States PermanentHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare ...
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Director, Biostatistics
2 weeks ago
Vera Therapeutics Brisbane, United StatesJob Description · Job DescriptionTitle: Director, Biostatistics · Location: Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance trea ...
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Associate Director, Biostatistics
2 weeks ago
Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Director, Biostatistics
2 weeks ago
Vera Therapeutics Brisbane, United StatesJob Description · Title: Director, Biostatistics · Location: Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that t ...
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Associate Director, Biostatistics
2 weeks ago
Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Director, Biostatistics
2 weeks ago
Vera Therapeutics, Inc. Brisbane, United StatesTitle: Director, Biostatistics · Location: · Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of ...
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Director, Biostatistics
2 weeks ago
ALX Oncology Holdings Inc. South San Francisco, United StatesALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding dom ...
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Director, Biostatistics
2 weeks ago
ALX Oncology Inc. South San Francisco, United StatesALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding dom ...
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Director, Biostatistics
2 weeks ago
Vera Therapeutics, Inc. Brisbane, United StatesTitle: Director, Biostatistics · Location: · Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Veras mission is to advance treatments that target the source o ...
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Associate Director of Biostatistics
2 weeks ago
TotalMed Staffing South San Francisco, United StatesSalary: $190,000 to $240,000 · On-Site: South San Fran, CA · Responsibilities: · Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams · Oversee all the studies for one compound to ensure the consistency ...
Executive Director Biostatistics - Menlo Park, United States - Summit Therapeutics Sub, Inc.
Description
Job Description
Job DescriptionLocation: Menlo Park, CA, or Remote West Coast US
Our Mission:
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities:
We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:
Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Overview of Role:
Serves as the project level biostatistician and provides leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.
Role and Responsibilities:
Experience, Education and Specialized Knowledge and Skills:
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's human resources department to obtain prior written authorization before referring any candidates to Summit.
Executive Director Biostatistics professionals in Menlo Park
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Vasken Guiragossian
Executive Creative Director