Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in California.

📋 Description

• Lead clinical studies, supervise a team, and manage statistical programming activities.

• Guide programmers in creating program specifications and design documents in collaboration with the project statistician.

• Oversee the programming of analysis datasets across various clinical trials.

• Act as the lead statistical programmer for designated projects as required.

• Manage and direct a team of statistical programmers and coordinate with matrix teams as necessary.

• Formulate a talent development strategy that aligns with departmental growth objectives.

• Offer programming expertise for analyses utilized in clinical study reports, presentations, and select publications.

• Provide programming expertise for intricate ad hoc data requests.

• Identify potential risks and spearhead the implementation of mitigation plans, including negotiations with both internal and external stakeholders.

• Ensure that analysis data and programming code comply with regulatory and company standards.

• Confirm that databases and external data sources fulfill analysis requirements across clinical trials.

• Create and update statistical programming protocols or guidelines.

• Assist in gathering technical documentation for internal and external audits.

• Execute other tasks as assigned by Leadership.

• Collaborate with cross-functional teams, clients, functional peer-group managers, and both internal and external representatives.

• Engage in and present at both internal and external meetings.

⛳️ Requirements

• Bachelor's Degree in Statistics, Mathematics, Computer Science, or a related field with 10 years of prior experience in statistical analysis, or a Master's Degree with 8 years of experience in a regulated industry.

• Proven success in project management and leadership skills.

• Demonstrated expertise in SAS and Windows operating systems.

• Class III Medical Device Experience is preferred.

• Experience with SDTM, ADAM, TLF, and Macros is preferred.

• Proficiency in MS Office Suite, including Word, PowerPoint, Access, and Excel is preferred.

• Exceptional written and verbal communication skills, along with strong interpersonal relationship skills, including negotiation and relationship management abilities.

• Capability to drive the achievement of objectives.

• Stay updated on new advancements in statistics and regulatory guidance.

• In-depth understanding of clinical trial and statistical programming procedures.

• Expert knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) pertinent to pharmaceutical/medical device research.

• Proven track record in managing personnel.

• Strong problem-solving, organizational, analytical, and critical thinking abilities.

• Demonstrated capability to oversee an assigned team and provide coaching and feedback, with hire/fire authority and collaboration with HR on employee relations.

• Experience in facilitating change and working with management and executive stakeholders.

• Ability to interact professionally across all organizational levels.

• Skill in managing multiple priorities in a fast-paced environment.

• Ability to work effectively within a team, including participating in and presenting at meetings with external representatives.

• Compliance with company rules and regulations, including pandemic protocols and Environmental Health & Safety standards.

• Ability to prevent injuries and environmental pollution within the area of influence/control.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A diverse range of benefits programs tailored to meet the various individual needs of employees and their families.