Summary:

The Senior Manager, Biostats will provide leadership in designing and implementation of clinical studies. Provide scope and engage CROs to ensure high-quality execution. Responsibilities also include authoring protocol, design elements, authoring SAPs or reviewing SAPs, TOCs and adherence to SOPs. Hands-on contributions including validation and independent verification of results are included in responsibilities, The senior manager may also lead study level or program level Biometrics meetings to ensure the plans are clearly communicated with CROs and Pacira stakeholders and progress is communicated on regular basis. Senior Manager may also participate in hiring talent as needed based on Biometrics lead guidance and expectations. Expert level knowledge is required for SAS or R.

Responsibilities

Essential Duties & Responsibilities:

• Develop statistical analysis plans for data and statistical outputs to support studies, abstracts, posters and publications including resource needs and timelines.
• Independently create SAS programs or validate data / statistical outputs.
• Independently perform quality control on analytical outputs created internally or by vendors.
• Provide guidance to programmers (Pacira and vendors) to ensure accuracy and use of best practices.
• Provide support in managing statistical programming performed by vendors.
• Provide reports to Associate Director or Head of Biometrics on status of statistical deliverables and outputs.
• Escalate issues in a timely manner to ensure study or program integrity.

Qualifications

Supervisory Responsibilities:

• Supervision and mentoring of statistical analyst or Manager, Biostatistics as applicable.
• Oversight of vendors including CROs.
• Project management within statistics.

Interaction:

This role interacts with clinical, regulatory functions including clinical study teams, data and statistical programmers, biostatisticians, project management, IT and external vendors.

Education and Experience:

• Master's degree from an accredited college or university in Statistics, Mathematics, Information Technology, Computer Science, or a related field; or Ph.D. in Statistics or a related field with a minimum of 2 years of clinical trial experience.
• Minimum 5 years of experience programming in SAS / SQL with at least 5 years in the pharmaceutical industry. Relevant experience obtained during a Ph.D. program may be considered.
• Minimum 3 years' experience managing projects. Relevant experience obtained during a Ph.D. program may be considered.

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.

Knowledge, Skills, and Abilities:

• Demonstrated resource management skills
• Problem solver and with strategic analytical thinking
• Proven project management skills
• Proven advanced programming ability in SAS or R including advanced level of knowledge of statistical methods including adaptive designs and guidances e.g. ICH E9
• Knowledge of Therapeutics area, endpoints and associated regulatory guidances
• Excellent written and oral English communication skills.

Physical Demands:

While performing the duties of this job, the employee will need to safely navigate a traditional office with cubicles, offices and conference rooms.

Work Environment:

The work will be in a typical office environment (cubicles, offices, conference rooms, etc.) with heavy computer use.

Benefits

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 $120,000 to $165,000 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.