Study Support Biostatistician- home-based

Contact: Terra Parsons -
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.