We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Specialist - SAS Programmer
- To conduct kick off meeting with client POC.
- To request reference study or sister study if available from client POC .
- Keep buffer time in hand when discussing timelines with client POC.eg GPS down Time unexpected leaves, additional request/update
- Time unexpected leaves, additional request/update.
- To check criticality leaves of programs with client POC to Promote programs In GPS and share with team member.
- To schedule meeting with Client POC for regular updates on study and query resolution.
- To check whether all team members have access to study folder. For example - raise study access request.
- To check request study document like Protocol CRF, SAP, PDS, Lab reference range (if applicable) etc. are available to start task.
- To conduct kick off meeting with internal team to make team members aware on Protocol, SAP, mock TFL Shell and volume etc.
- Keep team updated about templates like query tracker validation comment log etc and make the term responsible for maintaining document SOPs to be followed for deliverables.
- To perform task allocation for study and take into consideration the skillset of programmer during task allocation. For example – Complex task to be given to senior programmer.
- To be involved in complex programming like primary endpoints related outputs or route to respective SME if any.
- To guide term members if they have any difficulties in their respective work.
- To performed random review of the deliverables like log parser. Program and output etc. on ongoing basis. Ensure GPP is followed, and quality is maintained.
- Any conflicts in programming to be discussed with Trial statistician / Trial Programmer and no assumptions to be made.
- To schedule internal meeting with team members working on study and take updates on any challenges from team members regularly.
- To draft MOM of any meeting or important decision takes for studies and follow up pending action items.
- Keep project manager update on study status on regular basis.
- Highlight study risk & resources availability issues to project manager as and when observed
- Any deviation from any study or process, to be discussed with client and documented over mail project manager should be informed.
- To reach out to project manager to assign SME or statistician for additional review purpose.
- All communications and decisions through teams chat/over telephone with client POC/team members to be documented through emails as follow up.
- To appreciate team and team members for their hard work and dedications on timely basis.
Education and Experience
- Experience: Minimum 4 years
- University degree (Mathematics, Statistics, Computer Science or Life Science)
- Computer programming aptitude
- Comprehensive knowledge of Clinical Drug Development processes
- Ability to and ensure compliance with regulatory authorities, quality, and technical standards
- Good knowledge of spoken and written English; Good communication and presentation skills
Business and Functional Knowledge
- Comprehensive knowledge of drug development process and Good Clinical Practice (GCP)
- Awareness of regulatory requirements, e.g., Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines
- Multi-phase and different therapeutic areas experience
- SAS programming knowledge corresponding to advanced level
- Base SAS software (including macro and SQL)
- SAS graph
- In depth knowledge of SDTM/ADaMs/TFL principles and standards
- Ability to turn analysis needs into data structures
- Understanding content and structure of data in order to visualize potential usage
- Drug submission experience with a holistic approach on the data chain
- Submission data standards
- Be able to present and explain work performed to other subject matter experts or customer representatives
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms. Vineeta Bisht
Manager, Human Resources India