Manager Biostatistics
Actalent, Seattle, WA, United States
Job Title: Manager Biostatistics
Job Description The Manager of Biostatistics will serve as the statistical lead for multiple clinical trials, working closely with cross‑functional teams to ensure appropriate study design, statistical analysis, reporting, and interpretation of clinical trial results to achieve regulatory, scientific, and business objectives.
Responsibilities
Collaborate with clinical science, statistical programming, clinical data management, clinical operations, drug safety, translational research, regulatory, and project management teams to meet project deliverables and timelines for statistical data analysis and reporting.
Author statistical sections in protocols, including sample size calculations.
Develop Statistical Analysis Plans, mockups, and specifications of Tables, Listings, and Figures (TLFs) for clinical trials.
Apply advanced statistical methodologies to study design and clinical development plans.
Manage vendors and oversee statistical deliverables to ensure quality and adherence to timelines.
Conduct biomarker and exploratory analyses using advanced statistical methods.
Develop and maintain SAS macros, TLF templates, and programming standards.
Review and support the development of Case Report Form (CRF) design.
Participate in, review, and provide statistical input on study documents such as protocols, Investigator's Brochures (IB), Development Safety Update Reports (DSUR), and Clinical Study Reports (CSR).
Essential Skills
Expertise in Biostatistics.
Proficiency in programming, particularly with SAS and R.
Experience in the biotechnology or pharmaceutical industry.
Vendor oversight experience.
Proven experience in oncology, including hematology‑oncology or solid tumors.
Exposure to and experience in machine learning.
Strong knowledge of the drug development process and clinical trials.
Understanding of ICH guidance and Good Clinical Practice (GCP) standards.
Excellent verbal and written communication skills.
Ability to work effectively in a matrix team environment.
Additional Skills & Qualifications
Demonstrated programming skills in SAS and/or R.
Experience in biotech sector.
Knowledge of statistical methodologies.
Familiarity with machine learning applications.
Work Environment This position can be based in Seattle, Bothell, or South San Francisco, offering a dynamic work environment that supports collaboration across teams and locations.
Job Type & Location This is a Contract position based out of Seattle, WA.
Pay and Benefits The pay range for this position is $75.00 - $82.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long‑term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type This is a hybrid position in Seattle, WA.
Application Deadline This position is anticipated to close on Apr 27, 2026.
Actalent is an equal opportunity employer.
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Job Description The Manager of Biostatistics will serve as the statistical lead for multiple clinical trials, working closely with cross‑functional teams to ensure appropriate study design, statistical analysis, reporting, and interpretation of clinical trial results to achieve regulatory, scientific, and business objectives.
Responsibilities
Collaborate with clinical science, statistical programming, clinical data management, clinical operations, drug safety, translational research, regulatory, and project management teams to meet project deliverables and timelines for statistical data analysis and reporting.
Author statistical sections in protocols, including sample size calculations.
Develop Statistical Analysis Plans, mockups, and specifications of Tables, Listings, and Figures (TLFs) for clinical trials.
Apply advanced statistical methodologies to study design and clinical development plans.
Manage vendors and oversee statistical deliverables to ensure quality and adherence to timelines.
Conduct biomarker and exploratory analyses using advanced statistical methods.
Develop and maintain SAS macros, TLF templates, and programming standards.
Review and support the development of Case Report Form (CRF) design.
Participate in, review, and provide statistical input on study documents such as protocols, Investigator's Brochures (IB), Development Safety Update Reports (DSUR), and Clinical Study Reports (CSR).
Essential Skills
Expertise in Biostatistics.
Proficiency in programming, particularly with SAS and R.
Experience in the biotechnology or pharmaceutical industry.
Vendor oversight experience.
Proven experience in oncology, including hematology‑oncology or solid tumors.
Exposure to and experience in machine learning.
Strong knowledge of the drug development process and clinical trials.
Understanding of ICH guidance and Good Clinical Practice (GCP) standards.
Excellent verbal and written communication skills.
Ability to work effectively in a matrix team environment.
Additional Skills & Qualifications
Demonstrated programming skills in SAS and/or R.
Experience in biotech sector.
Knowledge of statistical methodologies.
Familiarity with machine learning applications.
Work Environment This position can be based in Seattle, Bothell, or South San Francisco, offering a dynamic work environment that supports collaboration across teams and locations.
Job Type & Location This is a Contract position based out of Seattle, WA.
Pay and Benefits The pay range for this position is $75.00 - $82.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long‑term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type This is a hybrid position in Seattle, WA.
Application Deadline This position is anticipated to close on Apr 27, 2026.
Actalent is an equal opportunity employer.
#J-18808-Ljbffr