Biostatistician

Company:

Location:

Work Schedule:

Experience:

About AlzaSyno Life Sciences:

AlzaSyno Life Sciences is a leading Contract Research Organization (CRO) dedicated to providing high-quality, full-service clinical research solutions to the global pharmaceutical, biotechnology, and medical device industries. We are committed to scientific excellence and accelerating the development of life-changing therapies.

Position Summary:

We are seeking a highly motivated and experienced Biostatistician to join our dynamic Biostatistics and Programming team. The ideal candidate will play a critical role in the design, analysis, and reporting of clinical trials, ensuring the highest standards of statistical integrity and regulatory compliance. You will collaborate closely with cross-functional teams to deliver robust statistical outputs that drive key development decisions.

Key Responsibilities:

1. Statistical Analysis Plan (SAP) & Protocol Development:

• Provide expert statistical input into the design of clinical trials, including sample size calculation, randomization, and endpoint selection.
• Author, review, and finalize detailed Statistical Analysis Plans (SAPs) for assigned studies.
• Develop and review statistical sections of clinical study protocols.

2. Data Standards & Programming:

• Utilize advanced statistical programming skills in 

  SAS

   (primary), 

  R

  , 

  STATA

  , and 

  SPSS

   to analyze clinical trial data.
• Develop and validate SAS programs for the generation of safety and efficacy analysis outputs, including 

  Tables, Listings, and Figures (TLFs)

  .
• Ensure adherence to 

  CDISC standards

  , including 

  SDTM

   and 

  ADaM

   models, for all datasets and deliverables.
• Perform quality control (QC) review of datasets and TLFs produced by other team members.

3. Clinical Study Reporting:

• Lead the statistical analysis and interpretation of clinical trial results.
• Author and review the statistical sections of Clinical Study Reports (CSRs), integrated summaries, and publications.
• Ensure all statistical deliverables are accurate, complete, and produced within agreed timelines.

4. Quality & Compliance:

• Ensure all statistical activities comply with 

  GCP

  , ICH guidelines, relevant regulatory requirements (FDA, EMA, etc.), and company SOPs.
• Serve as a key point of contact for 

  internal and external audits

   and regulatory inspections related to biostatistics.
• Implement and maintain best practices for programming and data validation.

5. Collaboration & Communication:

• Collaborate effectively with Clinical Data Management, Medical Writing, Pharmacovigilance, and Project Management teams.
• Communicate complex statistical concepts and results clearly and effectively to non-statistical colleagues and clients.

Qualifications & Skills:

• Education:

   Master's degree (M.Sc.) in Statistics or Biostatistics from a recognized university.

• Experience:

   Minimum of 5 years of experience as a Biostatistician within a Pharma, Biotech, or CRO environment.

• Technical Skills:

• Essential:

   High proficiency in 

  SAS

   (Base, Stat, Graph, Macro).

• Highly Desirable:

   Strong working knowledge of 

  R

  , 

  STATA

  , and 

  SPSS

  .
• In-depth knowledge of 

  CDISC standards

   (

  SDTM

  , 

  ADaM

  ).

• Therapeutic Knowledge:

   Experience across various therapeutic areas is preferred.

• Regulatory Knowledge:

   Thorough understanding of 

  GCP

  , ICH guidelines, and regulatory submission requirements.

• Soft Skills:

• Excellent problem-solving and analytical skills.

• Strong attention to detail and commitment to data quality.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Effective communication and interpersonal skills.

What We Offer:

• A competitive compensation and benefits package.
• Opportunities for professional growth and career development.
• A collaborative and supportive work environment.
• Exposure to a wide range of global clinical projects.