Senior Biostatistics Director

4 days ago


Princeton, New Jersey, United States Genmab Full time

About the Role

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below.

Key Responsibilities:

  • Act as lead and main point of contact related to Statistics for designated compound/indication
  • Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
  • Engage with regulatory authorities on compound/indication level discussions
  • Ensure consistency of statistical methods and data handling across trials
  • Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
  • Support compound responsible programmer in developing an integrated database specification

CDT member:

  • Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
  • Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
  • Drive design and synopsis development together with relevant stakeholders
  • Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
  • Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles

Trial Level:

  • Represent Genmab during meetings/congresses and courses and perform professional networking
  • Engage with regulatory authorities on trial level discussions
  • Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
  • Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
  • Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

Requirements:

  • Master's or PhD in a statistical discipline with 8+ years of experience in relevant technical area
  • Experience in statistical analysis, modelling and simulation and adaptive trial designs
  • Experience with drug development in biologics and targeted therapies preferred
  • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Proven performance in earlier role/comparable role

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment

You are a generous collaborator who can work in teams with diverse backgrounds

You are determined to do and be your best and take pride in enabling the best work of others on the team

You are not afraid to grapple with the unknown and be innovative

Genmab

Genmab is an international biotechnology company with a core purpose guiding its team to strive towards improving the lives of patients through innovative antibody therapeutics

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company

No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information



  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Biostatistics DirectorAbout the Role:Sun Pharmaceutical Industries, Inc. is seeking an experienced Senior Biostatistics Director to join our team. As a key member of our Biostatistics department, you will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Associate Director, BiostatisticsSun Pharmaceutical Industries, Inc. is seeking an experienced Associate Director of Biostatistics to join our team. This role will support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.The ideal candidate will have a strong...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job DescriptionSun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company with a strong presence in over 100 countries. We are seeking an experienced Associate Director of Biostatistics to join our team.The successful candidate will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Director of Biostatistics to join our team.The Director of Biostatistics will be responsible for leading the development of innovative and efficient clinical trials,...


  • Princeton, New Jersey, United States Rbw Consulting Full time

    Director BiostatisticsAt RBW Consulting, we're driven by a passion for innovation and a commitment to making a meaningful impact. As Director of Biostatistics, you'll play a critical role in shaping the future of cancer treatment by developing groundbreaking antibody products.Key Responsibilities:Lead statistical aspects for early and late-stage programs,...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries Inc. Full time

    Job Title: Associate Director, BiostatisticsSun Pharmaceutical Industries Ltd. is seeking an experienced Associate Director of Biostatistics to join our rapidly growing organization. This role will support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.Key Responsibilities:Serve...


  • Princeton, New Jersey, United States Genmab AS Full time

    About the RoleThe Associate Director, Biostatistics will lead the development of clinical development strategies and plans, providing statistical expertise to support the clinical development of compounds. This role will act as a statistical expert, supporting the clinical development of compounds as compound and/or indication lead for both early and...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a global revenue of over $5.1 billion, we provide high-quality, affordable medicines trusted by customers and patients worldwide.Job SummaryWe are seeking an experienced Associate Director...


  • Princeton, New Jersey, United States TAIHO ONCOLOGY INC Full time

    About the RoleTaiho Oncology Inc. is seeking a highly skilled Director, Biostatistics to join our team. As a key member of our biostatistics department, you will be responsible for leading the design and execution of clinical trials, analyzing and interpreting data, and authoring scientific and regulatory documents.Key ResponsibilitiesDesign and execute...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a rich history dating back to 1983, we have grown to become one of the largest generic pharmaceutical companies worldwide. Our commitment to delivering high-quality, affordable medicines...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Manager, BiostatisticsJob SummaryWe are seeking a highly skilled Senior Manager, Biostatistics to join our team at Sun Pharmaceutical Industries, Inc. The successful candidate will be responsible for providing statistical leadership and expertise to support the development of clinical trials.Key ResponsibilitiesProvide statistical...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Associate Director, BiostatisticsSun Pharmaceutical Industries Ltd. is a global specialty generic pharmaceutical company with a presence in over 100 countries. We provide high-quality, affordable medicines trusted by customers and patients worldwide.We are seeking an experienced Associate Director of Biostatistics to support the design, execution,...


  • Princeton, New Jersey, United States Sun Pharma Full time

    About Sun PharmaSun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a global revenue of over $5.1 billion, we provide high-quality, affordable medicines trusted by customers and patients worldwide.Job SummaryWe are seeking an experienced Associate Director of Biostatistics to join...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in over 100 countries. Our mission is to provide high-quality, affordable medicines to patients worldwide.Job Title: Associate Director, BiostatisticsWe are seeking an experienced Associate Director of Biostatistics...


  • Princeton, New Jersey, United States Sun Pharma Full time

    About the RoleAs a key member of our team, the Associate Director of Biostatistics will play a crucial role in supporting Phase 1-3 clinical research studies. This position requires a strong statistical background and excellent communication skills to work effectively with internal staff and vendors.Key ResponsibilitiesServe as the statistical lead on one or...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries Inc. Full time

    About the RoleSun Pharmaceutical Industries Ltd. is seeking an experienced Associate Director of Biostatistics to join our rapidly growing organization. This position will be responsible for supporting the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.Key Responsibilities Serve as...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a global revenue of over $5.1 billion, we provide high-quality, affordable medicines to customers and patients worldwide.Our company has a rich history, dating back to 1983, and has grown...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceAt Bristol Myers Squibb Company, we are committed to transforming patients' lives through science. As a Director of Biostatistics, you will play a critical role in this mission by leading the development of innovative and efficient clinical trials. Your expertise in statistical analysis and data interpretation will...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Manager, BiostatisticsThis position reports to the local area Lead within Biostatistics and Data Management (BDM) group at Sun Pharmaceutical Industries, Inc. The main responsibilities will include hands-on day-to-day support of one or more clinical studies. The position will provide oversight of all statistical activities during the lifecycle of the...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries Ltd.Sun Pharmaceutical Industries Ltd. is a leading global pharmaceutical company with a strong presence in over 100 countries. With a commitment to delivering high-quality, affordable medicines, we have established ourselves as a trusted partner for patients and customers worldwide.Job SummaryWe are seeking an experienced...