- Требуемый опыт работы
- 1 год
The Statistical Programmer will provide expert technical statistical responsibility for building programs to create SAS datasets for the clinical database, external data sources and other sources, while following clinical study protocol or statistical plan (i.e. provides input into development and validation of generic statistical programming procedures and develops generic statistical programming procedures). Will be responsible for all statistical deliverables (including Programming Plan, datasets for analysis purposes and programs preparation of statistical report, Programming Report, if applicable).
- Ability to join international CRO company and develop knowledge of clinical trials industry.
- Possibility of development of qualifications and skills.
- Onboarding process to enable you fast takeover of duties.
- Peer/Buddy/Mentor who will introduce you to the organization.
- Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed.
- Empowering workspace, offering opportunities to share ideas.
- Mentoring and training programs related to clinical trials, therapeutic areas, soft skills development.
- Sport card, healthcare coverage, additional benefits cafeteria, NNW insurance, additional days-off for certain occasions.
- Responsible for statistical programming of all relevant studies in company portfolio (including for example analysis dataset specifications; robust and flexible statistical tool macro programs or modules for standard output; data listings, summary reports, tables and figures as specified in Statistical Analysis Plan).
- Supports with preparation and maintenance of Standard Operating Procedures fulfilling all relevant industry guidelines.
- Develops Programming Plan and Report for conducted studies as per applicable SOPs.
- Prepares SDTM deliverables, including mapping specifications, datasets.
- Creates precise study programming reports together with the Biostatistician, in line with Statistical Analysis Plan.
- Works closely with the Biostatisticians, Statistical Programmers and study team to develop and implement specifications for the programming.
- Reviews of eCRF prior to finalization to ensure design criteria per protocol are met and all relevant information to support planned analyses is captured.
- Supports Data Management staff and provides support when needed to facilitate CDISC implementation.
- Develops Statistical Programmer knowledge by ongoing trainings and self-training. Maintains awareness of all applicable guidelines (e.g. ICH, EMA, FDA).
- Stands as Statistical Programmer communication point and maintains good relationships with study team and Sponsors (if applicable).
- Maintains awareness of and adherence to the schedule of established project timelines.
- Shares Statistical Programmer knowledge and experience and provides general training for all applicable company employees.
- Strong working knowledge of SAS computing package (at least 1 year of programming experience).
- MSc or educational equivalent in biostatistics or related field and at least 1 year of experience in this field.
- Excellent computer skills.
- Excellent written and verbal English communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- Strong commitment to quality.
- Ability to effectively manage multiple tasks and projects.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Ability to work independently and efficiently according to local regulations, SOPs, ICH GCP, GVP, EU Directives.
- Good communication and interpersonal skills, good analytical and negotiation skills.
- Available for traveling, including overnight stays as necessary.