Penfield Search Partners
Contact: Linda Aronova 646.882.9021 firstname.lastname@example.org
Position Summary: The Director, Statistical Programming will be responsible for day to day statistical programming tasks for all studies conducted by company and/or subsidiaries including oversight of CRO statistical programming activities and collaborate with other functional areas such as data management and biostatistics. The Director of Statistical Programming will provide technical support for ongoing trials, FDA submissions, publication and other business needs. The Director of Statistical Programming provides an expert-level hands-on support and technical leadership to all clinical development programs and regulatory submissions. The Director, Statistical Programming will report to the VP of biometrics and Data Management and will work closely with cross-functional teams on multiple clinical development programs. This position is a remote, work from home opportunity.
- Leads statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and approval of programming deliverables.
- Develops and maintains data management SOPs and policies as required to maintain overall quality and consistency of Statistical Programming.
- Participate and provide strategic guidance in study setup and initiation procedures such as CRF design and review. Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Efficiently manage CROs to meet timelines and quality deliveries. Oversee TLFs production and validation, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs. Establish optimal relationships with internal customers and colleagues and with new or existing strategic partners and vendors.
- Contribute to the strategic decision-making process involving programming issues for ongoing early and late phase clinical trials. Communicate how programming decisions impact other functional areas at company.
- Write or review or approve the data specifications for SDTM and ADaM. Create or validate SDTM, ADaM, and TLFs. Track and maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
- Proficient in applying SAS programming knowledge to solve problems related to non-routine situations and experienced in interpreting statistical analysis plans and developing analysis data set specifications.
- Work collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas; understand and perform in accordance with regulatory standards and drug development principles.
- Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package; plan, develop, test, and document SAS programs and macros for programming efficiency.
- Develop and utilize study metrics to monitor quality, project status, activities and budget and work with VP of Biometrics and Data Management to identify trends and provide updates for improvements on study level operational performance and quality metrics.
- Performs supervisory duties as needed including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of staff.
- Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans.
- Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements.
- Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
Skills, Qualifications, and Requirements:
- Bachelors Degree in Statistics, Mathematics, or Computer Science. Masters Degree preferred.
- Minimum 10 years of statistical programming experience in CRO, biotech, or pharmaceutical industry with at least 5 years management experience.
- Strategic leadership in a cross-functional team setting with extensive experience in an outsourced model, EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical terminology, medical coding dictionaries, and quality control processes.
- Strong hands-on SAS programing skills and working experience in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
- Advanced knowledge in GCP, ICH, GCP/ICH standards, 21 CFR Part 11 and FDA requirements with prior experience filing a NDA/MAA/BLA preferred.
- Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
- Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to work within cross-functional teams.
- Ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
- Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving; ability to prioritize and effectively manage multiple projects simultaneously.
- Ability to work with little or no supervision with accuracy and thoroughness. Excellent written and oral communication skills.