Summary:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

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.

Responsibilities

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.

Interaction:

The Manager - Biostatistics will interact with team members from clinical affairs, clinical operations, data management, medical writing, project management, regulatory affairs, and CRO partners.

Qualifications

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

Work Environment:

Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is located in cubicle setting.

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.