Contact: Terra Parsons -
teamnt@penfieldsearch.com
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
- Masters degree in Biostatistics, Statistics, or a related quantitative discipline preferred.
- Approximately 35 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.