Apply on Employer Site

MindMed · 12 hours ago

Associate Director, Statistical Programming

United States

Full-time

Remote

Lead/Staff, Director/Executive

$175K/yr - $200K/yr

12+ years exp

Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Associate Director, Statistical Programming will provide statistical programming support for clinical trials, ensuring high quality deliverables and collaborating with various teams to support clinical development and regulatory filing.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed

Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)

Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission

Work closely with study lead biostatistician to manage vendor's deliverables from quality to timeline

Perform independent validation (QC) to ensure accuracy of statistical vendor's deliverables from datasets to analytic outputs

Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers

Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning

Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format

Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures

Perform statistical analysis to support publications, and/or regulatory correspondence as needed

Perform other duties as assigned

Qualification

SASBiostatisticsStatistical ProgrammingPinnacle 21CDISC StandardsProject ManagementCollaborationDetail-orientedInterpersonal Skills

Required

Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 12 years of experience in providing statistical programming support in clinical trial setting

Deep understanding about data standards with rich experience in understanding Pinnacle 21 validation report and creating Define XML packages to support regulatory filing

Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED)

Demonstrated capacity of collaboration with biostatisticians, Clinical Data Management and colleagues from other functions to deliver common goals

Strong organizational and project management skills demonstrated interest in continued learning and growing

Proven to work well on multiple projects in a fast-paced environment

Detail-oriented and hold high standards of excellence for Statistical Programming's deliverables

Deliver and communicate effectively in the work-from-home environment

Excellent interpersonal skills and a good team player