Manager Biostatistics

Penfield Search Partners Ltd; New Jersey; Hybrid; USD 102,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid holidays

FTO

Parental Leave

Job summary

Penfield Search Partners Ltd. is seeking a Manager of Biostatistics in Northern New Jersey for a hybrid role.

The candidate will lead statistical activities across clinical programs, guide study design and analyses, and partner with CROs and cross-functional teams to inform regulatory decisions. The role requires a Master’s in statistics/biostatistics, at least 2 years in biotech/pharma, and proficiency in SAS (required) with R and CDISC as pluses.

Qualifications

• Master’s Degree in statistics/biostatistics from an accredited college or university.
• Minimum 2 years in biotech/pharma or related field.
• Experience in design, analysis, and reporting of randomized trials.

Responsibilities

• Provide statistical leadership for clinical programs and ensure quality deliverables.
• Manage studies from development through CSR and publication; collaborate with CROs.
• Serve as primary statistical contact for assigned programs and studies.
• Contribute to protocol development, study design, and sample size calculations.
• Review regulatory deliverables and ensure compliance with SOPs and standards.

Skills

Leadership

Communication

Statistical thinking

Education

Master's in statistics/biostatistics

Tools

SAS

R

CDISC

Job description

Manager Biostatistics Our client is a pioneer in non-opioid pain management and regenerative health solutions. They are developing next-generation innovations for chronic, postsurgical, and musculoskeletal pain and are looking for a Manager of Biostatistics to add to their growing team. This is a Hybrid role based in Northern NJ. The Manager, Biostatistics is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making.

Essential Duties & Responsibilities

• Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables.
• Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other statisticians and statistical programmers.
• Serve as the primary statistical point of contact for assigned programs and studies.
• Serve as a key contributor to protocol development and study design.
• Perform sample size calculations.
• Develop and/or review statistical analysis plans.
• Contribute to the design and analysis of clinical trial and real-world data to support evidence generation for company products from randomized controlled trials and observational studies.
• Establish effective collaboration with cross-functional team members, including clinical development, medical affairs, clinical operations, data management, and regulatory affairs.
• Review and approve statistical deliverables produced internally or by CRO partners, ensuring high quality deliverables and compliance with regulatory standards and company expectations.
• Manage biostatistics CRO partners, ensuring quality and adherence to SOPs.
• Partner with clinical and regulatory teams to proactively identify risks and mitigation strategies related to statistical design and analysis.
• Support interactions with regulatory authorities on statistical topics, including participation in meetings, responses to information requests, development of preparation materials and briefing book materials for meetings and communications with regulatory authorities.

Education and Experience

• Master’s Degree in statistics, biostatistics from accredited college or university
• Minimum 2 years of experience within the biotech/pharmaceuticals industry or a related field.
• Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.

Knowledge, Skills, and Abilities

• Strong understanding of clinical trial design principles, including adaptive designs.
• Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
• Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards.
• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
• Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
• Programming experience in SAS is required; experience in R is a plus.
• Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
• Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
• Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

Benefits

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave
• Pay Transparency

The base pay range for this role is $102,000 to $140,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.