We have a current opportunity for a Snr Director Statistical Programming on a permanent basis. The position will be based in California or Massachusetts. For further information about this position please apply.
Job Title: Senior Director of Statistical Programming
Salary: $230,000-$260,000 base
Position Overview: We are seeking an experienced and highly motivated Senior Director of Statistical Programming to lead our statistical programming team. This role is critical to our clinical development efforts and will involve overseeing the design, development, and implementation of statistical programming activities for our clinical trials.
Key Responsibilities:
- Lead and manage the statistical programming team, providing mentorship and guidance to junior programmers.
- Oversee the development, validation, and maintenance of SAS programs to support clinical trial data analysis and reporting.
- Collaborate with biostatisticians, data managers, and clinical teams to ensure the accuracy and integrity of clinical trial data.
- Develop and implement standard operating procedures (SOPs) for statistical programming activities.
- Ensure compliance with regulatory requirements and industry standards (e.g., CDISC, FDA, EMA).
- Participate in the preparation of statistical analysis plans (SAPs) and clinical study reports (CSRs).
- Provide strategic input on statistical programming aspects of clinical development plans.
- Stay current with industry trends and advancements in statistical programming methodologies.
Qualifications:
- Advanced degree (Master's or Ph.D.) in Statistics, Mathematics, Biostatistics, Computer Science, or a related field.
- Minimum of 14 years of experience in statistical programming within the biotech or pharmaceutical industry.
- Proven leadership experience with a track record of managing and developing high-performing teams.
- Expertise in SAS programming and familiarity with other statistical software (e.g., R, Python) is a plus.
- Early and late stage clinical trial experience
- Regulatory interraction experience
- Strong knowledge of clinical trial design, data management, and regulatory requirements.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work in a fast-paced, innovative environment.
- Career growth and development opportunities.
- A supportive and inclusive company culture.
