Associate Director, Biostatistics - Oncology

Key ResponsibilitiesThe Associate Director, Biostatistics will provide strategic and operational leadership in biostatistics for late-phase oncology clinical trials. This role involves designing, analyzing, and interpreting clinical study data to support the development and regulatory approval of oncology therapies. This is an onsite position and can be located at either our Gaithersburg, MD or the Conshohocken, PA sites.

Key Responsibilities:

Typical responsibilities of the Associate Director, Biostatistics include but are not limited to:

Clinical Trial Design and Analysis:

• Develop and implement statistical methodologies for late-phase oncology clinical trials.

• Collaborate with clinical and regulatory teams to design studies, select endpoints, and determine sample sizes.

• Oversee the execution of statistical analyses and ensure the accuracy and validity of results.

Regulatory Submissions:

• Prepare and review statistical sections of clinical study reports (CSRs), regulatory submissions, and other documentation.

• Interact with regulatory authorities to address statistical issues and provide guidance on data interpretation.

Project Leadership:

• Lead biostatistics activities for multiple oncology projects, ensuring timely and high-quality deliverables.

• Provide statistical expertise and guidance to project teams, including supporting the execution of clinical trials by collaborating with the cross-functional team to ensure smooth trial conduct and data integrity.

Innovation and Process Improvement:

• Evaluate and implement innovative statistical methods and technologies to enhance clinical trial design and analysis.

• Contribute to the development and revision of standard operating procedures (SOPs) and best practices within the biostatistics department.

Collaboration and Communication:

• Work closely with cross-functional teams, including clinical science, regulatory affairs, and medical affairs, to support decision-making and strategy development.

• Present statistical findings and interpretations to internal and external stakeholders, including regulatory agencies and scientific communities.

Education, Experience and Knowledge:

Essential Qualifications:

• Ph.D. in Biostatistics, Statistics, or related field with at least 5 years’ experience (M.S. with at least 8 years’ relevant experience) within the pharmaceutical or biotechnology industry, or other relevant area, preferably with a focus on oncology.

• Proven track record of leading biostatistics activities for late-phase clinical trials and supporting regulatory submissions.

• In-depth knowledge of statistical methodologies and regulatory requirements for clinical trials.

• Ability to effectively represent the Biostatistics and work both independently and collaboratively in a cross-functional team environment.

• Excellent analytical, problem-solving, and written and verbal communication skills.

• Strong knowledge of programming in SAS and/or R.About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.