Study Biostatistician- home-based

Contact:
Terra Parsons - teamnt

No 3rd party candidates

The study support Biostatistician will provide statistical support across multiple clinical studies, working closely with senior biostatisticians to help manage study deliverables, analyses, and day-to-day statistical activities. This role is ideal for an early-career biostatistician with pharmaceutical industry experience who is comfortable working across multiple studies and contributing to a variety of statistical deliverables.

The individual will support two biostatisticians who oversee a broad portfolio of studies, helping ensure statistical activities are completed accurately, efficiently, and according to study timelines.

Responsibilities Provide statistical support for multiple clinical studies under the guidance of senior biostatisticians.

Assist with the development, review, and quality control of statistical deliverables, including tables, figures, and listings (TFLs).Support the development and review of statistical analysis plans (SAPs), table shells, specifications, and other study documentation.

Perform statistical analyses and assist with the interpretation of clinical study data.

Review clinical data, outputs, and programming deliverables for accuracy, consistency, and completeness.

Collaborate with Statistical Programming, Data Management, Clinical, and other cross-functional team members to support study activities and timelines.

Assist with responding to statistical and data-related questions from study team members.

Participate in study team meetings and provide statistical support as needed.

Support database review, data cleaning activities, and preparation for database lock.

Assist senior biostatisticians with ad hoc analyses, presentations, publications, regulatory requests, and other statistical deliverables.

Maintain appropriate documentation and ensure work is performed in accordance with applicable SOPs, regulatory requirements, and industry standards.

Effectively prioritize assignments across multiple concurrent studies and communicate potential timeline or resource concerns.

Qualifications Master’s degree in Biostatistics, Statistics, or a related quantitative discipline preferred.

Approximately 3–5 years of biostatistics experience within the pharmaceutical, biotechnology, or related clinical research industry.

Experience supporting clinical trials and working with clinical study data.

Working knowledge of statistical methodologies commonly used in clinical research.

Working proficiency in SAS and R, including experience performing statistical analyses and reviewing statistical outputs.

Familiarity with CDISC standards, including SDTM and ADaM, preferred.

Experience reviewing TFLs and other statistical programming outputs.

Understanding of clinical trial processes, GCP, and regulatory expectations.

Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.

Strong communication and collaboration skills with the ability to work effectively under the direction of more senior biostatisticians.

Ideal Candidate The ideal candidate is a collaborative, detail-oriented biostatistician who enjoys being hands-on and supporting multiple studies. This individual does not need to be a senior study lead but should have enough pharmaceutical industry experience to understand clinical trial workflows, take ownership of assigned statistical tasks, and provide dependable support with limited day-to-day supervision.