Associate Director, Biostatistics

Summit Therapeutics

11d•$174,000 - $203,000

About The Position

The Associate Director, Biostatistics serves as the project-level biostatistician and provides leadership within the biostatistics function. The role develops and executes statistical strategy, study design, statistical analyses, and regulatory submissions for oncology clinical trials. The position partners with clinical science, regulatory, and other team members on clinical development plans, authors key clinical, regulatory, and statistical documents, and supports exceptional delivery and interpretation of clinical data. The role also develops and implements biostatistics department policies, standards, procedures, and work instructions in coordination with the department leader and other functions. It represents the biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.

Requirements

Ph.D. in Statistics, Biostatistics, or an equivalent area and 6 or more years of biopharmaceutical industry experience; an MS in a related discipline with extensive industry and leadership experience (8 or more years) may be considered.
Strong proficiency with software and tools commonly used in biostatistics, such as SAS and R.
Good understanding of clinical trial processes and statistical programming requirements.
Working knowledge of ICH, FDA, and GCP regulations and guidelines.
Attention to detail, accuracy, and confidentiality.
Clear and concise oral and written communication skills.
Ability to multitask effectively and manage time-sensitive, highly confidential documents.
Ability to communicate effectively and explain complex ideas in an understandable way.
Ability to work in a fast-paced, demanding, and collaborative environment.

Responsibilities

Provide technical leadership and statistical support to clinical development through the design and conduct of oncology clinical studies.
Support protocol development by assessing trial design and sample size and proposing meaningful, efficient statistical methodologies.
Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics-related submission activities, and post-submission strategies and responses.
Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with clinical and other teams on interim reports, final reports, and publications.
Write or review meeting-package sections and assist with developing and reviewing documents required for regulatory submissions and other regulatory processes.
Review vendor data-transfer specifications and ADaM programming specifications.
Lead the assessment and introduction of novel statistical methodologies.
Represent the biostatistics function or biometrics department on cross-functional teams.
Work with the department leader to develop and implement departmental policies, standards, and procedures.
Collaborate with clinical operations, data management, and CROs 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 support project success.
Attend meetings with the FDA or other health authorities to support ongoing agreement on project development.
Perform other duties as assigned.