Statistician

Katalyst CRO; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Lead Statistician in San Francisco, California. This role requires an individual with strong SAS programming skills and a master’s degree in a related field. You will be responsible for overseeing statistical analyses for clinical trials and leading project tasks independently. The ideal candidate will have over 3 years of experience and demonstrate solid project management and mentoring abilities.

Join our dynamic team and contribute to impactful statistical analyses and reports while also supporting and guiding junior team members in a collaborative environment.

Qualifications

• 3+ years of relevant experience in a similar role.
• Strong understanding of statistical methodologies.
• Ability to work independently and lead projects.

Responsibilities

• Lead project tasks as a statistician delivering quality results.
• Manage statistical analysis in clinical trials.
• Mentor team members and ensure protocol compliance.
• Contribute to report preparation and documentation.
• Communicate project scope and budget with management.

Skills

SAS programming

Statistical principles

Project management

Team collaboration

Strong communication skills

Education

Master's degree in statistics, biostatistics, mathematics or related field

Tools

SAS BASE

SAS STAT

SAS MACRO

SAS GRAPH

Job description

Job Description

Looking for someone who has leadership skills. Great early role to gain extensive industry experience. SAS programming a MUST. Writes/reviews analysis plans and guides others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Provides specifications for analysis database, oversees its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel regarding database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.

Responsibilities

• Functions independently as a project lead or lead statistician to deliver the project tasks/responsibilities.
• Performs project management functions relating to the administrative and scientific activities of specific project work and team members.
• Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.
• Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.
• Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Follows departmental procedures for statistical analyses and programming work.
• Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
• Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation.
• Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
• Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.
• Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
• Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.
• Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning.
• Provides general infrastructure support to the Department (present / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires).
• Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.

Requirements

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
• Master's degree in statistics, biostatistics, mathematics or related field
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities

• Strong SAS programming skills.
• Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures.
• Capable of directing and promoting teamwork in a multi-disciplinary team setting.
• Strong understanding of statistical principles and strong statistical skills.
• Solid project management skills, as shown through management of multiple projects.
• Demonstrated initiative and motivation.
• Strong written and verbal communications skills including proficiency in the English language.
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects.
• Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other departments.