- Lead and oversee biostatistical activities for one of the late-stage clinical programs for the leading molecule
- Responsible for applying relevant statistical methods to the practice of clinical trial data summaries and interpretations
- Represent Biometrics function to work with Health Authorities and Key Opinion Leaders as needed
- Provide biostatistics input into drug development plan; work with cross-functional team to design and operationalize clinical studies; provide statistical input in the evaluation, interpretation, and preparation of study results
- Be accountable and responsible for statistical deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, etc.
- Assist with resolution of unique queries that may arise during the data management and statistical analysis process
- Provide ad-hoc data listings and summary information per requests
- Participate in developing and maintaining relevant Biostatistics processes to ensure quality of study data and accuracy of statistical outputs
- Perform quality control with respect to the data to be analyzed and the programs to be used for the analysis
- Define processes and perform additional (alternative) quality checks focusing on key efficacy and safety endpoints to ensure validity of data and accuracy of analyses.
- Continue to improve the quality process to ensure the growing requirement of data and output validations
- Manage/ support the preparation of data packages for NDA and other regulatory submissions.
- Select, manage, and supervise CROs.
- May mentor junior team members or contractors as needed.
The ideal candidate - Ph.D. degree or equivalent education in Biostatistics with a minimum of 8 years' experience (or Master with minimum of 10 years) providing statistical analysis and programming support in the biotech/pharmaceutical industry.
- Immunology trials experience is desirable
- Comprehensive and detailed knowledge of statistical experimental design, analysis, and clinical trial requirements
- Demonstrated proficiency with statistical software such as R, SAS
- Ability to work in a regulated environment and adhere to company SOPs and procedures
- Ability to manage workflows and activities to meet department timelines
- Ability to manage deliverables with competing priorities and influence others
- Well-developed critical information seeking and analytical thinking skills
- Strong interpersonal and effective communication (oral and written) skills
- Thorough and strong attention to detail and consistency
- Experience in coaching and/or managing biostatistics staff is preferred but not required
Education - Ph.D. degree or equivalent education in Biostatistics with a minimum of 8 years' experience (or Master's degree or equivalent education with minimum of 10 years)
Alumis Values - Elevate
- Challenge
- Nurture
This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.
The salary range for this position is $240,000 – $260,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices.Alumis Inc. is an equal opportunity employer.
-
Associate Director Biostatistics
Found in: beBee S2 US - 2 weeks ago
Proclinical San Francisco, United States PermanentAssociate Director Biostatistics - Permanent - RemoteProclinical Staffing is seeking an Associate Director Biostatistics to join a cutting-edge pharmaceutical company. This is a permanent role with the opportunity to work remotely. · Primary ResponsibilitiesThe Associate Director ...
-
AD/Director Biostatistics
Found in: Appcast Linkedin GBL C2 - 6 days ago
Thor Companies Palo Alto, United StatesAd/Director Biostatistics · Individual Contributor role to start · Supporting the Head of Biostatistics in Oncology studies · Hybrid: Palo Alto, CA · Expertise in Oncology or Solid Tumor required · Phase II-III (taking over two studies) · Accelerated Approval Pathway/Accelerated ...
-
AD/Director Biostatistics
Found in: Jooble US O C2 - 1 day ago
Thor Companies Palo Alto, CA, United StatesAd/Director Biostatistics · Individual Contributor role to start · Supporting the Head of Biostatistics in Oncology studies · Hybrid: Palo Alto, CA · Expertise in Oncology or Solid Tumor required · Phase II-III (taking over two studies) · Accelerated Approval Pathway/Acceler ...
-
Associate Director, Biostatistics
Found in: Jooble US O C2 - 4 days ago
Arcellx Redwood City, CA, 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 ...
-
Associate Director, Biostatistics, Oncology
Found in: Jooble US O C2 - 1 day ago
Ascendis Pharma Palo Alto, CA, United StatesJob Description Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. · Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. · We are applying our TransCon technology to build ...
-
Associate Director, Biostatistics, Oncology
Found in: Jooble US O C2 - 1 day ago
Ascendis Pharma Palo Alto, CA, United StatesJob Description · Job Description · Here 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 adv ...
-
Associate Director, Biostatistics, Oncology
Found in: ZipRecruiter Test10S US C2 - 2 days 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 ...
-
Senior Director Clinical Data Management
Found in: Appcast Linkedin GBL C2 - 9 hours ago
Meet South San Francisco, United StatesJoin Our Team as Senior Director of Clinical Data Management · Are you passionate about leading clinical data strategies and driving excellence in data management? We're seeking a dynamic Senior Director of Clinical Data Management to join our team in South San Francisco · About ...
-
postdoctoral fellow
Found in: MyJobHelper US C2 - 2 days ago
Genentech South San Francisco, CA , USA, United StatesThe Position · We advance science so that we all have more time with the people we love. · As a postdoctoral fellow at Genentech, you will join a prestigious community of early career researchers and kickstart your journey toward becoming a scientific leader in biotechnology and ...
-
Senior Director, Head of Statistical Programming
Found in: ZipRecruiter Test10P US C2 - 2 days ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
-
Director, Clinical Scientist
Found in: Appcast Linkedin GBL C2 - 13 hours ago
RemeGen Biosciences South San Francisco, United States OTHERORGANIZATION · RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insi ...
-
Medical Director/Senior Medical Director, Clinical Development
Found in: Lensa US 4 C2 - 4 days ago
Allogene Therapeutics South San Francisco, United StatesJob DescriptionAbout Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a ma ...
-
Director, Clinical Quality Assurance
Found in: Lensa US 4 C2 - 2 days ago
Pliant Therapeutics South San Francisco, United StatesDescription · The Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for all assigned activities that ensure Pliant Therapeutics sponsored clinical trials adhered to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Plia ...
-
Medical Director/Senior Medical Director, Clinical Development
Found in: Lensa US 4 C2 - 1 day ago
Allogene Therapeutics South San Francisco, United StatesJob Description · About Allogene: · Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led ...
-
Medical Director/Senior Medical Director, Clinical Development
Found in: Lensa US 4 C2 - 4 days ago
Allogene South San Francisco, United StatesAbout Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team ...
-
senior medical director, pharmacovigilance
Found in: MyJobHelper US C2 - 2 days ago
ACELYRIN, INC. South San Francisco, CA , USA, United StatesAt ACELYRIN, INC., the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency. Our key value of courageous caring means putting patients first and having the courage needed to ...
-
clinical research associate
Found in: MyJobHelper US C2 - 2 days ago
Assembly Biosciences, Inc. South San Francisco, CA , USA, United StatesPosition Title: Clinical Research Associate · Reports to: Associate Director, Clinical Operations · Status: Regular, Full-time, Exempt · Summary: We are seeking a highly motivated Clinical Research Associate (CRA) to be responsible for supporting the Clinical Development Team to ...
-
Medical Director, Ophthalmology
Found in: Lensa US 4 C2 - 4 days ago
Annexon, Inc. South San Francisco, United States Full timeWork Location · Corporate Headquarters (South San Francisco, CA) Onsite – Hybrid · Non-local candidates will be considered · Position Summary · The Medical Director, Ophthalmology will play a critical role in helping to shape and execute our ophthalmology strategy, serving as par ...
-
Principal Biostatistician
Found in: beBee S2 US - 4 weeks ago
Freenome South San Francisco, United States Full timeWhy join Freenome? · Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treat ...
-
Director, Clinical Scientist
Found in: ZipRecruiter Test10S US C2 - 2 days ago
Remegen Biosciences, Inc. South San Francisco, United StatesJob Description · Job DescriptionORGANIZATION · RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Mary ...
Director, Biostatistics - South San Francisco, United States - Alumis Inc.
Description
Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an experienced Director of Biostatistics who will lead and oversee the biostatistical activities for one of the late-stage clinical programs for our leading molecule. He/she will be responsible for applying relevant statistical methods to the practice of clinical trial data analysis and interpretations. This person will be also responsible for overseeing the quality of the Biostatistics & Statistical Programming Analysis (SPA) generated statistical tables, listings, and graphical presentations of clinical data, and supporting the preparation of regulatory documents (such as study protocols, statistical analysis plans, clinical study reports, integrated summaries of efficacy and safety) and other presentation and publication materials. This role may involve the supervision of junior biostatisticians and/or working closely with all Biometrics functions in developing and maintaining relevant Biometrics processes to ensure the quality of study data and the accuracy of statistical outputs. This position reports to the Vice President, Head of Biostatistics and Statistical Programming.
Responsibilities
