Study Support Biostatistician- home-based

Penfield Search Partners; Milford (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking an early-career Biostatistician in Milford, CT to provide statistical support across multiple clinical studies under senior biostatisticians.

This role involves developing and reviewing TFLs, SAPs, and other study documentation, and collaborating with cross-functional teams to meet timelines. The ideal candidate will have a Master’s in Biostatistics and 3–5 years of pharmaceutical/clinical research experience, with strong SAS and R skills and familiarity

Qualifications

• Master's degree in Biostatistics or related quantitative discipline preferred.
• Approximately 3–5 years of biostatistics experience within pharmaceutical/biotech or related clinical research industry.
• Experience supporting clinical trials and working with clinical study data.
• Working knowledge of statistical methodologies used in clinical research.
• Proficiency in SAS and R, including performing analyses and reviewing outputs.
• Familiarity with CDISC SDTM and ADaM, preferred.
• Experience reviewing TFLs and statistical outputs.
• Understanding of GCP and regulatory expectations.
• Strong attention to detail and ability to manage multiple priorities.
• Strong collaboration and communication skills.

Responsibilities

• Provide statistical support for multiple clinical studies under guidance of senior biostatisticians.
• Assist with development, review, and QC of statistical deliverables (tables, figures, listings).
• Support development and review of SAPs, table shells, specifications, and other study documentation.
• Perform statistical analyses and help interpret clinical data.
• Review data, outputs, and programming deliverables for accuracy and consistency.
• Collaborate with cross-functional teams to support study activities and timelines.
• Respond to statistical and data-related questions from study team members.
• Participate in study team meetings and provide statistical support as needed.
• Support database review and data cleaning prior to database lock.
• Assist with ad hoc analyses, presentations, publications, and regulatory requests.
• Maintain documentation per SOPs, regulatory requirements, and industry standards.
• Prioritize assignments across concurrent studies and flag timeline/resource concerns.

Skills

Biostatistics

SAS

R

CDISC SDTM

ADaM

Study management

Communication

Education

Master's degree in Biostatistics

Tools

SAS

R

Job description

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.