Jobs @ SimulStat

Senior Statistical Programmer; Direct Hire – San Diego, CA

The Senior Statistical Programmer will lead statistical programming support to major clinical studies, including ad hoc analysis for clinical development, drug safety, regulatory affair, medical affair, and research group. He/she will be working with CROs to ensure projects meet agree upon timeline with good quality, developing ISS/ISE, converting legacy study data to CDISC for submission,… Read more »

Contract Remote Epidemiologist

Skills: Skills at the level of principle investigator and recent direct implementation Program management – Meeting Agenda, Minutes Power calculations PY projection Other epi methods (comparative safety analysis, meta-analysis, IPTW) Literature reviews Algorithm development for use in database analysis Biostat Software, database expertise Protocol/grant writing submission Pharmaceutical experience and knowledge of regulatory environment timelines and… Read more »

Remote Epidemiologist – Contract

This position will support all therapeutics areas and products. The majority of the work is ad hoc. The group is looking for someone who is quantitatively oriented, good at writing SAS code, experienced with literature searches, attention to detail, ability to catch errors, comfortable in a fast paced environment with tight deadlines many times. Basic… Read more »

Remote Sr. Statistical Programmer – Contract

- 6 month potentially renewable contract – Write SDTM and ADaM specs – Generate SDTM domains, ADaM datasets, and Define.xml files – Create analysis datasets, tables, figures, and listings to support the analysis of clinical trials data – Experience using Pinnacle 21 validation software

Director of Data Management; San Diego, CA

We are seeking a leader to head the DM team in overseeing several ongoing trials, starting-up new trials and providing DM vendor oversight activities across the development programs. The incumbent will work closely with the head of Biometrics in identifying project DM demands and resource needs. Provides hands-on support to project teams by leading data… Read more »

Principal Data Manager; San Diego, CA

We are seeking a Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data… Read more »

Senior Data Manager; San Diego, CA

  We are seeking a Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of several trials with a CRO and additional support with upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both… Read more »

Seattle Contract Statistician

Onsite Seattle preferred but will consider remote for ideal candidate W2 Only – 6 month contract Responsible for statistical aspects of clinical and pre-clinical research projects including study design, sample size estimation, patient randomization, case report form development, writing statistical analysis plans, statistical analysis and interpretation of data, and reporting of results. Work with SAS… Read more »

Onsite SAS programmer, Seattle or remote for senior candidate, W2 only

*W2 Only – 12 month contract Primarily an implementation role, requiring ability to take a block of work and self-organize into smaller deliverables RESPONSIBILITIES: Review and/or develop SDTM and ADaM specifications Implement SDTM and ADaM specifications, either as source or QC side of double-programming Program TFLs from specifications, which may require back-and-forth with Stats, so… Read more »

Remote ADaM Expert Consultant, one year renewable contract

Remote ADaM Expert Consultant, one year renewable contract RESPONSIBILITIES: Lead the development of ADaM data standards Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation Develop and maintain Data Element Standard (DES) content and ADaM Implementation Guidance and documentation Author/Maintain developed ADaM Implementation Guides and implementation examples… Read more »